Annuloplasty ring delivery catheters

ABSTRACT

Apparatus is provided for repairing a cardiac valve, the apparatus including a catheter sized for delivery through vasculature of a subject and an elongated and flexible annuloplasty structure having an annuloplasty structure axis. The annuloplasty structure is sized and configured for delivery to a heart of the subject through the catheter substantially along a catheter axis of the catheter while the annuloplasty structure axis is substantially parallel to the catheter axis. The apparatus also includes a plurality of anchors configured for delivery to a region of cardiac tissue from a proximal end of the catheter toward a distal end of the catheter and substantially along the annuloplasty structure axis and the catheter axis while at least a portion of the annuloplasty structure is within a delivery passage of the catheter. Other embodiments are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a Continuation of U.S. patent applicationSer. No. 15/977,271 to Sheps et al., entitled “Annuloplasty ringdelivery catheters,” filed May 11, 2018, which is a Continuation of U.S.patent application Ser. No. 14/273,155 to Sheps et al., entitled,“Annuloplasty ring delivery catheters,” filed May 8, 2014 (now U.S. Pat.No. 9,968,452), which:

a. claims priority from U.S. Provisional Patent Application 61/820,979to Sheps et al., entitled, “Controlled steering functionality forimplant-delivery tool,” filed May 8, 2013, which is related to U.S.Provisional Patent Application 61/557,082 to Sheps et al., entitled,“Controlled steering functionality for implant-delivery tool,” filedNov. 8, 2011; U.S. Provisional Patent Application 61/717,303 to Sheps etal., entitled, “Controlled steering functionality for implant-deliverytool,” filed Oct. 23, 2012; PCT Patent Application PCT/IL2012/050451 toSheps et al., entitled, “Controlled steering functionality forimplant-delivery tool,” filed on Nov. 8, 2012, which published asWO/2013/069019; and U.S. Provisional Patent Application 61/745,848, toSheps et al., entitled, “Controlled steering functionality forimplant-delivery tool,” filed Dec. 26, 2012;

b. is a continuation-in-part of U.S. patent application Ser. No.13/319,030 to Zipory et al., entitled, “Deployment techniques forannuloplasty ring and over-wire rotation tool, filed on Dec. 16, 2011,which published as US 2012/0078355, issued as U.S. Pat. No. 9,636,224,and is a US national phase application of PCT ApplicationPCT/IL2010/000358 to Zipory et al., entitled, “Deployment techniques forannuloplasty ring and over-wire rotation tool, filed on May 4, 2010,which published as WO 10/128503 and which:

-   -   i. is a continuation-in-part of and claims the priority from        U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed May 4, 2009, which issued as U.S. Pat. No.        8,147,542;    -   ii. is a continuation-in-part of and claims the priority from        U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        May 7, 2009, which issued as U.S. Pat. No. 8,715,342;    -   iii. is a continuation-in-part of and claims the priority from        U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed        Aug. 27, 2009, which published as US 2010/0161042, and which        issued as U.S. Pat. No. 8,808,368;    -   iv. is a continuation-in-part of and claims the priority from        U.S. patent application Ser. No. 12/689,635 to Zipory et al.,        entitled, “Over-wire rotation tool,” filed on Jan. 19, 2010,        which issued as U.S. Pat. No. 8,545,553; and    -   v. is a continuation-in-part of and claims the priority from        U.S. patent application Ser. No. 12/689,693 to Hammer et al.,        entitled, “Deployment techniques for annuloplasty ring,” filed        on Jan. 19, 2010, which published as US 2010/0280605, and which        issued as U.S. Pat. No. 8,911,494;

c. is a continuation-in-part of U.S. patent application Ser. No.14/242,151 to Zipory et al., entitled, “Annuloplasty ring withintra-ring anchoring,” filed Apr. 1, 2014, which published as US2014/0343668, and which is a continuation of U.S. patent applicationSer. No. 12/437,103 to Zipory et al., entitled, “Annuloplasty ring withintra-ring anchoring,” filed May 7, 2009, which issued as U.S. Pat. No.8,715,342;

d. is a continuation-in-part of PCT Patent Application PCT/IL2012/050451to Sheps et al., entitled, “Controlled steering functionality forimplant-delivery tool,” filed on Nov. 8, 2012, which published asWO/2013/069019 and which claims priority from U.S. Provisional PatentApplication 61/557,082 to Sheps et al., entitled, “Controlled steeringfunctionality for implant-delivery tool,” filed Nov. 8, 2011; and

e. is a continuation-in-part of U.S. patent application Ser. No.14/357,040 to Sheps et al., filed on May 8, 2014, which issued as U.S.Pat. No. 9,724,192, and which is a US national phase application of PCTPatent Application PCT/IL2012/050451 to Sheps et al., entitled,“Controlled steering functionality for implant-delivery tool,” filed onNov. 8, 2012, which published as WO/2013/069019 and which claimspriority from U.S. Provisional Patent Application 61/557,082 to Sheps etal., entitled, “Controlled steering functionality for implant-deliverytool,” filed Nov. 8, 2011.

All of these applications are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates in general to valve repair, and morespecifically to repair of an atrioventricular valve of a patient.

BACKGROUND OF THE INVENTION

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

SUMMARY OF THE INVENTION

In some applications of the present invention, an adjustable partialannuloplasty ring is provided for repairing a dilated valve annulus ofan atrioventricular valve, such as a mitral valve. The annuloplasty ringcomprises a flexible sleeve and a plurality of anchors. An anchordeployment manipulator is advanced into a lumen of the sleeve, and, fromwithin the lumen, deploys the anchors through a wall of the sleeve andinto cardiac tissue, thereby anchoring the sleeve around a portion ofthe valve annulus. The anchors are typically deployed from a distal endof the manipulator while the distal end is positioned such that acentral longitudinal axis through the distal end of the manipulatorforms an angle with a surface of the cardiac tissue of between about 20and 90 degrees, e.g., between about 45 and 90 degrees, e.g., betweenabout 75 and 90 degrees, such as about 90 degrees. Typically, theanchors are deployed from the distal end of the manipulator into thecardiac tissue in a direction parallel to the central longitudinal axisthrough the distal end of the manipulator.

In some applications of the present invention, the anchors are deployedfrom the left atrium into the upper region of the ventricular wall nearthe atrium, tissue of which generally provides more secure anchoringthan does the atrial wall. The above-mentioned angle of deploymentenables such deployment into the upper region of the ventricular wall.

In some applications of the present invention, the anchor deploymentmanipulator comprises a steerable outer tube in which is positioned ananchor driver having an elongated, flexible shaft. Rotation of theanchor driver screws the anchors into the cardiac tissue. The anchorsmay, for example, be helical in shape. For some applications, theplurality of anchors are applied using the manipulator by loading afirst one of the anchors onto the anchor driver, and deploying theanchor into the cardiac tissue. The anchor driver is withdrawn from thebody of the subject, and a second one of the anchors is loaded onto theanchor driver. The anchor driver is reintroduced into the sleeve of theannuloplasty ring, and the second anchor is deployed. These steps arerepeated until all of the anchors have been deployed. Alternatively, theanchor driver is configured to simultaneously hold a plurality ofanchors, and to deploy them one at a time.

Typically, the manipulator is gradually withdrawn in a proximaldirection during the anchoring procedure as anchors are deployed. Thefirst anchor is thus deployed most distally in the sleeve (generally ator within a few millimeters of the distal tip of the sleeve), and eachsubsequent anchor is deployed more proximally.

The annuloplasty ring is typically configured to be placed onlypartially around the valve annulus (i.e., to assume a C-shape), and,once anchored in place, to be contracted so as to circumferentiallytighten the valve annulus. To this end, the annuloplasty ring comprisesa flexible contracting member such as a wire, which is typicallypositioned within the lumen of the sleeve. The annuloplasty ring furthercomprises an adjustment mechanism which facilitates contracting of theannuloplasty ring. For some applications, the adjustment mechanismcomprises a spool to which a first end of the contracting member iscoupled. The spool is positioned in a vicinity of either the proximal orthe distal end of the sleeve. A second end of the contracting member iscoupled to the sleeve in a vicinity of the end of the sleeve oppositethe end to which the spool is positioned. Rotation of the spool winds aportion of the contracting member around the spool, thereby pulling thefar end of the ring toward the spool and tightening the ring. For someapplications, the spool is positioned in a vicinity of the distal end ofthe sleeve, and is oriented such that a driving interface thereof isaccessible from within the sleeve. A screwdriver tool is inserted intothe sleeve, and used to rotate the spool via the driving interface ofthe spool.

All of the tools and elements of the annuloplasty system that areintroduced into left atrium are contained within the sleeve of theannuloplasty ring, which reduces the risk that any elements of thesystem will accidentally be released to the blood circulation, or damagesurrounding tissue. In addition, the lumen of the sleeve providesguidance if it should be necessary to return to a previously deployedanchor, such as to tighten, loosen, remove, or relocate the anchor. Forsome applications, the anchors comprise helical screws, which facilitatesuch adjusting or removing.

The annuloplasty ring may be advanced toward the annulus of a valve inany suitable procedure, e.g., a transcatheter procedure, a minimallyinvasive procedure, or an open heart procedure.

In some applications of the present invention, a multi-component tubularsystem is provided for accessing a heart of a patient. The systemcomprises one or more steerable guiding catheters configured fordirecting the passage of devices therethrough into the heart. Themulti-component tubular system is configured to deliver an implant in adesired orientation to an annulus of a cardiac valve of the patient andto facilitate anchoring of the implant to the annulus. For someapplications of the present invention, the guiding system is advancedtransluminally or transthoracically accessing an atrium of the heart.Typically, the system comprises two or more steerable catheters. A firstcatheter has a distal portion that is steerable to a first desiredspatial orientation. A second catheter is disposed within the firstcatheter and has a distal portion that is steerable to a second desiredspatial orientation. The system provides techniques andrelative-spatial-orientation-controlling devices for controlling theorientation of the distal portion of the second catheter with respect tothe first catheter without substantially distorting the first spatialorientation of the distal portion of the first catheter. For someapplications, the relative-spatial-orientation-controlling devicecomprises a rotational locking mechanism provided by components of thecatheter system.

For some applications, the first catheter is configured to provide aslit at the distal portion thereof (i.e., a first component of therotational locking mechanism), and the second catheter is configured toprovide a depressible pin (i.e., a second component of the rotationallocking mechanism) at a distal portion thereof. The second catheter isconfigured for advancement through a lumen of the first catheter. Duringthe advancement, the pin is depressed by an inner wall of the firstcatheter. The pin is configured to return to a resting state in whichthe pin is not depressed, when the pin is aligned with the slit of thefirst catheter. Since the first catheter provides the slit at a distalportion thereof, the second catheter may be introduced within the lumenof the first catheter in any suitable rotational orientation withrespect to the first catheter.

The distal portion of the first catheter may be steered in a suitabledirection following advancement of the first catheter throughvasculature of the patient. Following the advancement of the firstcatheter and steering of the distal portion of the first catheter in anyone or more suitable planes, the second catheter is advanced through thefirst catheter. The second catheter is advanced through the firstcatheter until at least a distal-most portion of the distal portion ofthe second catheter is exposed from within the lumen of the firstcatheter. Depending on the relative rotational orientation of the secondcatheter with respect to the first catheter, the physician may need torotate the second catheter in order to engage the pin with the slit andlock the second catheter with respect to the first catheter. Suchlocking enables steering of the distal portion of the second catheter inany one or more suitable planes with respect to the distal portion ofthe first catheter in a manner which substantially maintains the spatialand rotational orientation of the first catheter during the steering ofthe second catheter. With such a rotational locking, during steering ofthe second catheter, the second catheter will not tend to assume therotational configuration and angular, curved orientation of the firstcatheter, and vice versa. Additionally, the first catheter may befurther steered without substantially disrupting the spatial, angular,and rotational orientation of the distal portion of the second catheter,and vice versa.

There is therefore provided, in accordance with some applications of thepresent invention, apparatus for use with a subject, the apparatusincluding:

a first catheter, shaped to define a first lumen therethrough, a distalend portion of the first catheter being transluminally advanceable to avicinity of an anatomical site;

a second catheter, shaped to define a second lumen therethrough, adistal end portion of the second catheter being advanceable through thefirst lumen and out of a distal end of the first lumen; and

a longitudinal implant, advanceable through at least part of the secondlumen and out of a distal end of the second lumen, the first and secondcatheters are assembled:

-   -   to facilitate sliding of the second catheter within the first        catheter, and sliding of the implant within the second catheter,    -   to configure the first catheter, the second catheter, and the        implant to assume a multi-bend formation in which:        -   a first bend of the formation separates a first domain of            the formation from a second domain of the formation,        -   a second bend of the formation separates the second domain            of the formation from a third domain of the formation,        -   the first domain includes at least (1) part of the first            catheter and (2) part of the second catheter,        -   the second domain includes the distal end portion of the            second catheter, part of the implant, and none of the first            catheter, and        -   the third domain includes part of the implant, none of the            first catheter, and none of the second catheter.

In some applications of the present invention, a third bend of theformation separates the first domain from a fourth domain, and thefourth domain includes at least (1) part of the first catheter and (2)part of the second catheter.

In some applications of the present invention, the first catheter, thesecond catheter and the implant are transluminally advanceable such thatat least the second domain and the first domain are disposed within aheart atrium of the subject.

In some applications of the present invention, the first domain of themulti-bend formation includes part of the first catheter, part of thesecond catheter, and part of the implant.

In some applications of the present invention, the apparatus furtherincludes a proximal extracorporeal portion that is configured tofacilitate the sliding of the second catheter within the first catheter,and the sliding of the implant within the second catheter, and toconfigure the first catheter, the second catheter and the implant toassume the multi-bend formation.

In some applications of the present invention, the apparatus furtherincludes:

a first locking mechanism located at respective distal portions of thefirst and second catheters, the first locking mechanism being configuredto rotationally lock the first catheter with respect to the secondcatheter at the respective distal portions; and

a second locking mechanism, the proximal extracorporeal portionincluding the second locking mechanism, the second locking mechanismbeing configured to rotationally lock the first catheter with respect tothe second catheter at the proximal extracorporeal portion.

In some applications of the present invention, the first lockingmechanism includes a detent at the distal portion of the secondcatheter, and the second catheter is shaped so as to define a slit atthe distal portion thereof for engaging the detent of the first catheterto lock the second catheter to the first catheter.

In some applications of the present invention, the second lockingmechanism includes a housing coupled to the first catheter, the housingbeing shaped so as to define a groove, and the second catheter is shapedso as to define a protrusion at a proximal portion thereof for engagingthe groove of the housing to lock the second catheter to the firstcatheter.

In some applications of the present invention, the first and the secondlocking mechanisms are configured to lock substantially simultaneously.

In some applications of the present invention, the proximalextracorporeal portion is configured to bend the distal end portion ofthe first catheter.

In some applications of the present invention, when the distal endportion of the second catheter is disposed outside of the distal end ofthe first lumen, the proximal extracorporeal portion is configured tobend the distal end portion of the second catheter independently ofbending of the distal end portion of the first catheter.

In some applications of the present invention, the proximalextracorporeal portion is configured to steer the first catheter.

In some applications of the present invention, the proximalextracorporeal portion is configured to steer the second catheter.

In some applications of the present invention, the proximalextracorporeal portion includes:

a first control mechanism configured to steer the first catheter; and

a second control mechanism configured to steer the second catheter;

the first control mechanism and the second control mechanism areconfigured to control relative movement of the annuloplasty structure,by controlling the first and second catheters, respectively.

In some applications of the present invention, the apparatus furtherincludes at least one tissue anchor configured for implantation throughat least a portion of a wall of the implant while at least a portion ofthe implant is within the second lumen of the second catheter.

In some applications of the present invention, the at least one tissueanchor is configured to anchor a distal end portion of the longitudinalimplant to tissue of the subject, and the tissue anchor facilitates theformation of the second bend.

In some applications of the present invention, the apparatus furtherincludes a channel having an opening at a distal end thereof, thechannel being advanceable within a lumen of the implant, the channel isconfigured to sandwich the portion of the wall of the implant between(1) the opening in the channel, and a (2) region of cardiac tissue.

In some applications of the present invention, the at least one tissueanchor is configured to anchor a distal end portion of the longitudinalimplant to tissue of the subject, and the tissue anchor and the channelfacilitate the formation of the second bend.

In some applications of the present invention, the channel is steerable.

In some applications of the present invention, the tissue anchor isconfigured to be deployed from the opening and through the portion ofthe wall during the sandwiching.

In some applications of the present invention, the apparatus furtherincludes an adjustment mechanism coupled to the implant at a distalportion of the implant at the third domain, the adjustment mechanismbeing configured to adjust a degree of tension of the implant.

In some applications of the present invention, the apparatus furtherincludes a guide member that is reversibly coupled to the adjustmentmechanism at a distal portion of the guide member, agenerally-triangular shape is formed in the apparatus between: (1) theguide member, (2) the distal portion of the implant structure at atleast a portion of the third domain, and (3) at least a portion of thesecond domain.

In some applications of the present invention, the apparatus furtherincludes a channel having an opening at a distal end thereof, thechannel being advanceable within a lumen of the implant, the seconddomain includes a distal end portion of the channel, and agenerally-triangular shape is formed in the apparatus between: (1) theguide member, (2) the distal portion of the implant structure at atleast a portion of the third domain, and (3) the distal end portion ofthe channel.

In some applications of the present invention, the first and secondcatheters are independently steerable.

There is further provided, in accordance with some applications of thepresent invention, a method including:

transluminally advancing to a vicinity of an anatomical site a distalend portion of a first catheter, shaped to define a first lumentherethrough;

advancing a distal end of a second catheter through the first lumen ofthe first catheter, the second catheter being shaped to define a secondlumen therethrough;

advancing a longitudinal implant through at least part of the secondlumen and out of a distal end of the second lumen;

facilitating sliding of the second catheter within the first catheter,and sliding of the implant within the second catheter; and

configuring the first catheter, the second catheter, and the implant toassume a multi-bend formation in which:

-   -   a first bend of the formation separates a first domain of the        formation from a second domain of the formation,    -   a second bend of the formation separates the second domain of        the formation from a third domain of the formation,    -   the first domain includes at least (1) part of the first        catheter and (2) part of the second catheter,    -   the second domain includes the distal end portion of the second        catheter, part of the implant, and none of the first catheter,        and    -   the third domain includes part of the implant, none of the first        catheter, and none of the second catheter.

In some applications of the present invention, the method furtherincludes:

-   -   advancing through a lumen of the implant a channel having an        opening at a distal end thereof; and    -   sandwiching the portion of the wall of the implant between (1)        the opening in the channel, and a (2) region of cardiac tissue.

In some applications of the present invention, deploying the tissueanchor includes deploying the tissue anchor from the opening and throughthe portion of the wall during the sandwiching.

There is yet further provided, in accordance with some applications ofthe present invention, apparatus for repairing a cardiac valve, theapparatus including:

a catheter sized for delivery through vasculature of a subject, thecatheter defining a delivery passage and having an elongated catheteraxis extending therethrough;

an elongated and flexible annuloplasty structure having an elongatedlumen therein and a structure axis extending along the lumen, theannuloplasty structure is sized and configured for delivery to the heartthrough the catheter substantially along the catheter axis while thestructure axis is substantially parallel to the catheter axis; and

a plurality of anchors, configured for delivery to a region of cardiactissue from a proximal end of the catheter toward a distal end of thecatheter and substantially along the structure axis and the catheteraxis while at least a portion of the annuloplasty structure is withinthe passage of the catheter.

In some applications of the present invention, the apparatus furtherincludes an elongated and flexible anchor delivery channel sized andconfigured to extend within the structure lumen while at least a portionof the annuloplasty structure is within the passage of the catheter.

In some applications of the present invention, the apparatus furtherincludes a first control mechanism and a second control mechanism, thefirst and the second control mechanisms are configured to enableindependent movement of the catheter and the anchor delivery channel,respectively.

In some applications of the present invention, the anchor deliverychannel is configured to be advanced with the annuloplasty structureduring a period when the catheter is maintained in a substantiallyconstant position.

In some applications of the present invention, the first controlmechanism and the second control mechanism are configured to enableincremental release of the annuloplasty structure from a distal end ofthe channel as the plurality of anchors are sequentially deployed fromthe anchor delivery channel.

In some applications of the present invention, the plurality of anchorsare configured for location within the anchor delivery channel, a distalend of the anchor delivery channel is configured for location within thestructure lumen, and the annuloplasty structure is configured forlocation within the delivery passage.

In some applications of the present invention, the cardiac valve is amitral valve.

In some applications of the present invention, the apparatus furtherincludes an elongated introducer shaft sized for delivery through thevasculature, the introducer shaft defining a lumen and having anelongated shaft axis extending therethrough, the lumen is sized andconfigured to hold at least a portion of the catheter therein while thecatheter axis is substantially parallel to the shaft axis.

In some applications of the present invention, further including acatheter control mechanism and an introducer control mechanismconfigured to enable independent movement of the catheter and theintroducer shaft.

In some applications of the present invention, the apparatus furtherincludes a first locking mechanism located at a distal region of thecatheter and a second locking mechanism located at a proximal region ofthe catheter, the first and the second locking mechanisms are configuredto inhibit rotation of the catheter.

In some applications of the present invention, the first lockingmechanism includes a detent.

In some applications of the present invention, the first and the secondlocking mechanisms are configured to lock substantially simultaneously.

There is additionally provided, in accordance with some applications ofthe present invention, a device for repairing a cardiac valve, thedevice including:

a catheter sized and configured for delivery through vasculature of asubject, the catheter defining a delivery passage and having anelongated catheter axis extending therethrough; and

an elongated and flexible annuloplasty structure contained within thecatheter and having an elongated lumen therein and a structure axisextending along the lumen, the annuloplasty structure is sized andconfigured for delivery to a heart of the subject through the cathetersubstantially along the catheter axis while the structure axis issubstantially parallel to the catheter axis, and the annuloplastystructure is constructed of a material configured to be pierced byanchors delivered from within the annuloplasty structure.

There is yet additionally provided, in accordance with some applicationsof the present invention, apparatus, including:

a catheter;

an implant, slidable through the catheter, and including a sleeve;

a reference-force member, slidable through the catheter, and configuredsuch that sliding of the reference-force member distally through thecatheter pushes the implant distally through the catheter; and

a stiffening element:

-   -   stiffer than the sleeve,    -   couplable to the sleeve so as to inhibit a flexibility of the        sleeve, and    -   couplable to the reference-force member such that movement of        the reference-force member away from the sleeve decouples the        stiffening element from the sleeve.

In some applications of the present invention, the stiffening element iscouplable to the sleeve and to the reference-force member such thatprogressive proximal movement of the reference-force member away fromthe sleeve reduces the inhibition of the flexibility of progressivelyproximal portions of the sleeve.

In some applications of the present invention, the stiffening element iscouplable to the sleeve and to the reference-force member such thatprogressive proximal movement of the reference-force member away fromthe sleeve decouples the stiffening element from progressively proximalportions of the sleeve.

In some applications of the present invention, the stiffening element iscouplable to the sleeve by being threaded a plurality of times throughthe sleeve, and the movement of the reference-force member away from thesleeve decouples the stiffening element from the sleeve by unthreadingthe stiffening element from the sleeve.

In some applications of the present invention, the stiffening elementincludes a stiffening wire.

In some applications of the present invention, the reference-forcemember includes a reference-force tube that defines a lumentherethrough.

In some applications of the present invention, the reference-force tubeis reversibly couplable to the implant.

In some applications of the present invention, the sleeve defines alumen, and, when the reference-force tube is coupled to the implant, thelumen of the reference-force tube is in fluid communication with thelumen of the sleeve.

There is also provided, in accordance with some applications of thepresent invention, apparatus for use with a subject, the apparatusincluding:

a catheter, shaped to define a lumen therethrough, a distal end portionof the catheter being transluminally advanceable to a vicinity of ananatomical site, the catheter having a first steerable segment and asecond steerable segment, the first steerable segment being steerable ina first plane, and the second steerable segment being steerable in asecond plane which is at a non-zero angle with respect to the firstplane; and

a longitudinal implant, advanceable through at least part of the lumenand out of a distal end of the lumen, the catheter and the implant areassembled to configure the catheter and the implant to assume amulti-bend formation in which:

-   -   a first bend of the formation separates a first domain of the        formation from a second domain of the formation,    -   a second bend of the formation separates the second domain of        the formation from a third domain of the formation,    -   the first domain includes at least (1) a distal part of the        first steering segment of the catheter and (2) a proximal part        of the implant,    -   the second domain includes (1) a distal part of the second        steering segment of the catheter and (2) a middle part of the        implant, and none of the first steering segment, and    -   the third domain includes a distal part of the implant and none        of the catheter.

In some applications of the present invention, the second steerablesegment is steerable in a second plane which is perpendicular withrespect to the first plane.

In some applications of the present invention, the catheter includes:

-   -   a first pull ring and at least one first-segment steering wire        configured to steer the first steerable segment, and    -   a second pull ring and at least one second-segment steering wire        configured to steer the second steerable segment.

In some applications of the present invention, the apparatus furtherincludes an adjustment mechanism coupled to the implant at a distalportion of the implant at the third domain, the adjustment mechanismbeing configured to adjust a degree of tension of the implant.

In some applications of the present invention, the apparatus furtherincludes a guide member that is reversibly coupled to the adjustmentmechanism at a distal portion of the guide member, agenerally-triangular shape is formed in the apparatus between: (1) theguide member, (2) the distal portion of the implant structure at atleast a portion of the third domain, and (3) at least a portion of thesecond domain.

In some applications of the present invention, the apparatus furtherincludes a channel having an opening at a distal end thereof, thechannel being advanceable within a lumen of the implant, the seconddomain includes a distal end portion of the channel, and agenerally-triangular shape is formed in the apparatus between: (1) theguide member, (2) the distal portion of the implant structure at atleast a portion of the third domain, and (3) the distal end portion ofthe channel.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are schematic illustrations of an adjustable partialannuloplasty ring in a non-contracted state, in accordance withrespective applications of the present invention;

FIG. 2 is a schematic longitudinal cross-sectional illustration of ananchor deployment manipulator, in accordance with some applications ofthe present invention;

FIG. 3 is a schematic longitudinal cross-sectional illustration of theanchor deployment manipulator of FIG. 2 advanced into the annuloplastyring of FIG. 1A, in accordance with some applications of the presentinvention;

FIG. 4 is a schematic cross-sectional illustration of the anchordeployment manipulator of FIG. 2 advanced into the annuloplasty ring ofFIG. 1A or 1B, taken along section Iv-Iv of FIG. 3, in accordance withsome applications of the present invention;

FIGS. 5A-B are schematic illustrations of a screwdriver tool being usedto rotate a spool of an adjustment mechanism of the rings of FIGS. 1Aand 1B, respective, in accordance with respective applications of thepresent invention;

FIGS. 6A-I are schematic illustrations of a procedure for implanting theannuloplasty ring of FIG. 1A to repair a mitral valve, in accordancewith some applications of the present invention;

FIG. 7 is a schematic illustration of the deployment of an anchor intocardiac tissue, in accordance with some applications of the presentinvention;

FIG. 8 is a schematic illustration of the system of FIGS. 1-4 comprisinga flexible pusher element, in accordance with some applications of thepresent invention;

FIG. 9 is a schematic illustration of a pusher tube applied to aproximal end of the sleeve of FIGS. 1-4, in accordance with someapplications of the present invention;

FIGS. 10 and 11 are schematic illustrations of the system of FIGS. 1-4comprising a steerable tube, in accordance with some applications of thepresent invention;

FIG. 12 is a schematic illustration of the system of FIGS. 1-4comprising a pulling wire, in accordance with some applications of thepresent invention;

FIGS. 13-14 are schematic illustrations of multi-component tubularsystem for delivering and anchoring an implant and for controlling arelative spatial orientation of components of the catheter system, inaccordance with some applications of the present invention;

FIGS. 15A-E are schematic illustrations of cross-sectional images ofcomponents of the catheter system of FIGS. 13-14, in accordance withsome applications of the present invention;

FIGS. 16-18 are schematic illustrations of components of the cathetersystem of FIGS. 13-14, in accordance with some applications of thepresent invention;

FIGS. 19A-B are schematic illustrations of components of the cathetersystem of FIGS. 13-14, in accordance with some other applications of thepresent invention;

FIGS. 20A-I are schematic illustrations of a procedure for implanting anannuloplasty ring structure to repair a mitral valve, in accordance withsome applications of the present invention;

FIG. 21 is a schematic illustration of a procedure for implanting anannuloplasty ring structure to repair a tricuspid valve, in accordancewith some applications of the present invention;

FIGS. 22A-D are schematic illustrations of an indicator and lockingsystem comprising a protrusion and a housing, or cradle, shaped todefine a groove, in accordance with some applications of the presentinvention;

FIGS. 23A-C are schematic illustrations of a tissue anchor, inaccordance with some applications of the present invention;

FIG. 24 is a schematic illustration of a state of a distal portion of amulti-component tubular system within the heart of a subject, inaccordance with some applications of the invention;

FIG. 25 is a schematic illustration of a kit of components of thecatheter system of FIGS. 13-14, in accordance with some applications ofthe invention;

FIG. 26 is a schematic illustration of a stiffening element, inaccordance with some applications of the present invention;

FIGS. 27A-B are schematic illustrations of a steerable catheter havingmultiple variable steering segments, in accordance with someapplications of the present invention; and

FIG. 28 is a schematic illustration of a state of a distal portion ofthe steerable catheter of FIGS. 27A-B, in accordance with someapplications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

FIGS. 1A-4 are schematic illustrations of a system 10 for repairing adilated atrioventricular valve, such as a mitral valve, in accordancewith some applications of the present invention. System 10 comprises alongitudinal implant comprising an adjustable partial annuloplasty ring3022, shown alone in FIGS. 1A and 1B in a non-contracted state, and ananchor deployment manipulator 61, shown alone in FIG. 2. Annuloplastyring 3022 comprises a flexible sleeve 26. Anchor deployment manipulator61 is advanced into sleeve 26, as shown in FIGS. 3 and 4, and, fromwithin the sleeve, deploys anchors 32 through a wall of the sleeve intocardiac tissue, thereby anchoring the ring around a portion of the valveannulus.

FIGS. 1A and 1B are schematic illustration of annuloplasty ring 3022 ina non-contracted state, in accordance with some applications of thepresent invention. Sleeve 26 is typically configured to be placed onlypartially around the valve annulus (i.e., to assume a C-shape), and,once anchored in place, to be contracted so as to circumferentiallytighten the valve annulus. Alternatively, the ring is configured to beplaced entirely around the valve annulus. In order to tighten theannulus, annuloplasty ring 3022 comprises a flexible elongatedcontracting member 226 that extends along the ring.

Annuloplasty ring 3022 further comprises an adjustment mechanism 40,which facilitates contracting of the annuloplasty ring. Adjustmentmechanism 40 is described in more detail hereinbelow. In addition, thering comprises a plurality of anchors 32, typically between about 5 andabout 20 anchors, such as about 10 or about 16 anchors. In FIGS. 1A and1B, anchors 32 are shown prior to their insertion into ring 3022, whilein FIG. 3 one of the anchors is shown deployed through the wall ofsleeve 26, and a second one of the anchors is shown during deployment byanchor deployment manipulator 61. The insertion of the anchors into thesleeve and deployment of the anchors into cardiac tissue is described indetail hereinbelow.

Flexible sleeve 26 may comprise a braided, knitted, or woven mesh or atubular structure comprising ePTFE. For some applications, the braidcomprises metal and fabric fibers. The metal fibers, which may compriseNitinol for example, may help define the shape of the sleeve, e.g., holdthe sleeve open to provide space for passage and manipulation ofdeployment manipulator 61 within the sleeve. The fabric fibers maypromote tissue growth into the braid. Optionally, the sleeve is somewhatelastic, which gives the sleeve a tendency to longitudinally contract,thereby helping tighten the sleeve. For example, the sleeve may bebellows- or accordion-shaped.

Typically, the sleeve is configured to have a tendency to assume astraight shape. This straightness helps the surgeon locate the next sitefor each subsequent anchor during the implantation procedure, asdescribed hereinbelow with reference to FIGS. 6A-I. For example, becausethe sleeve assumes a generally straight shape, the sleeve may helpprovide an indication of distance between adjacent anchoring sites.

For some applications, the sleeve is configured to have a controllablyvariable stiffness. For example, a somewhat stiff wire may be placed inthe sleeve to provide the stiffness, and subsequently be removed at theconclusion of the implantation procedure when the stiffness is no longeruseful.

Elongated contracting member 226 comprises a wire, a ribbon, a rope, ora band, which typically comprises a flexible and/or superelasticmaterial, e.g., nitinol, polyester, stainless steel, or cobalt chrome.In some applications, contracting member 226 comprises a braidedpolyester suture (e.g., Ticron). In some applications, contractingmember 226 is coated with polytetrafluoroethylene (PTFE). In someapplications, contracting member 226 comprises a plurality of wires thatare intertwined to form a rope structure.

For some applications, contracting member 226 is positioned at leastpartially within a lumen of the sleeve 26, such as entirely within thelumen (as shown in FIGS. 1A-B, 5A-B, 6H, and 6I). For some applicationsin which the contracting member is positioned partially within thelumen, the contracting member is sewn into the wall of the sleeve, suchthat the contracting member is alternatingly inside and outside of thesleeve along the length of the sleeve (as shown in FIGS. 3, 8, and 9).Optionally, sleeve 26 defines an internal channel within which member226 is positioned (configuration not shown). Alternatively, thecontracting member is disposed outside the lumen of the sleeve, such asalongside an outer wall of the sleeve. For example, sleeve 26 may definean external channel within which member 226 is positioned, or the sleevemay comprise or be shaped so as to define external coupling elements,such as loops or rings (configuration not shown). For some applications,contracting member 226 is positioned approximately opposite the anchors.

In an embodiment of the present invention, adjustment mechanism 40comprises a housing 44 which houses a spool 46, i.e., a rotatablestructure, to which a first end 47 of contracting member 226 is coupled.Spool 46 is positioned in a vicinity of (e.g., within 1 cm of) either adistal end 51 of sleeve 26, as shown in FIGS. 1A and 3, or a proximalend 49 of sleeve 26, as shown in FIG. 1B. A second end 53 of contractingmember 226 is coupled to the sleeve in a vicinity of (e.g., within 1 cmof) the end of the sleeve opposite the end to which the spool ispositioned. In the configuration shown in FIGS. 1A and 3, second end 53of contracting member 226 is coupled to the sleeve in a vicinity ofproximal end 49 of the sleeve, while in the configuration shown in FIG.1B, the second end of the contracting member is coupled to the sleeve ina vicinity of distal end 51 of the sleeve. Rotation of spool 46 winds aportion of the contracting member around the spool, thereby pulling thefar end of the ring toward the spool and shortening and tightening thering.

Alternatively, in some configurations, spool 46 is positioned at anintermediary position along the sleeve, rather than in a vicinity of oneof the ends. For these configurations, contracting member 226 comprisestwo contracting members, which are respectively connected to the twoends of the sleeve, and both of which are connected to the spool.Rotating the spool contracts both contracting members. Theseconfigurations may be implemented using techniques described in U.S.patent application Ser. No. 12/341,960 to Cabiri, which published as US2010/0161047, issued as U.S. Pat. No. 8,241,351, and which isincorporated herein by reference, with reference to FIG. 15 thereof.

Spool 46 is shaped to provide a hole 42 or other coupling mechanism forcoupling first end 47 of contracting member 226 to the spool, andthereby to adjustment mechanism 40. Spool 46 is shaped to define adriving interface 48. For some applications, driving interface 48 isfemale. For example, the interface may be shaped to define a channelwhich extends through the cylindrical portion of spool 46 from anopening provided by an upper surface 3050 of spool 46 to an openingprovided by a lower surface 3052 of spool 46. Alternatively, drivinginterface 48 is shaped so as to define an indentation (e.g., a groove)that does not extend entirely through the cylindrical portion of thespool. Further alternatively, driving interface 48 is male, and definesa protrusion, e.g., a hexagonal head or a head having another shape.

A distal portion of a screwdriver tool 80, which is describedhereinbelow with reference to FIGS. 5A-B, engages spool 46 via drivinginterface 48 and rotates spool 46 in response to a rotational forceapplied to the screwdriver. The rotational force applied to thescrewdriver tool rotates spool 46 via the portion of the screwdrivertool that engages driving interface 48 of spool 46.

Spool 46 typically comprises a locking mechanism that prevents rotationof the spool after contracting member 226 has been tightened. Forexample, locking techniques may be used that are described withreference to FIG. 4 of above-mentioned U.S. application Ser. No.12/341,960 to Cabiri, which published as US 2010/0161047 and which isincorporated herein by reference.

Alternatively, in an embodiment of the present invention, adjustmentmechanism 40 is configured to tighten contracting member 226, crimp thecontracting member to hold the contracting member taut, and subsequentlycut the excess length of the contracting member.

FIG. 2 is a schematic longitudinal cross-sectional illustration ofanchor deployment manipulator 61, FIG. 3 is a schematic longitudinalcross-sectional illustration of the anchor deployment manipulatoradvanced into annuloplasty ring 3022, and FIG. 4 is a schematiccross-sectional illustration of the anchor deployment manipulatoradvanced into the annuloplasty ring, taken along section Iv-Iv of FIG.3, in accordance with some applications of the present invention. Anchordeployment manipulator 61 is advanced into a lumen of sleeve 26, and,from within the lumen, deploys anchors 32 through a wall of the sleeveand into cardiac tissue, thereby anchoring the sleeve around a portionof the valve annulus. Typically, annuloplasty ring 3022 and anchordeployment manipulator 61 are introduced into the heart via a sheath2104, as described hereinbelow with reference to FIGS. 6A-I.

In an embodiment of the present invention, at least one of anchors 32 isdeployed from a distal end 3060 of manipulator 61 while the distal endis positioned such that a central longitudinal axis 3062 through distalend 3060 of manipulator 61 forms an angle α (alpha) of between about 20and 90 degrees, e.g., between about 45 and 90 degrees, with the wall ofsleeve 26 at the point at which the anchor penetrates the wall, such asbetween about 75 and 90 degrees, e.g., about 90 degrees. (In FIG. 3, aline 64 schematically illustrates the plane tangential to the wall ofthe sleeve at the anchor-penetration point.) This anchor-penetrationpoint is typically at a portion of the sleeve that extends distallybeyond the distal end of outer tube 3066 of deployment manipulator 61(which is described hereinbelow), i.e., that is no longer in contactwith the outer surface of outer tube 3066. Typically, all of the anchorsare deployed at such angles, with the possible exception of the firstanchor deployed near the distal end of the sleeve.

For some applications, at least one of anchors 32 is deployed fromdistal end 3060 of manipulator 61 while distal end 3060 is positionedsuch that longitudinal axis 3062 through distal end 3060 of manipulator61 forms an angle β (beta) of between about 20 and 90 degrees (such asbetween about 45 and 90 degrees, e.g., such as between about 75 and 90degrees, e.g., about 90 degrees) with a line 3065 defined by (a) a firstpoint 3067 at which the anchor currently being deployed penetrates thewall of the sleeve and (b) a second point 3069 at which a most recentlypreviously deployed anchor penetrates the wall of sleeve 26. Typically,all of the anchors are deployed at such angles, with the exception ofthe first anchor deployed near the distal end of the sleeve.

Typically, the anchors are deployed from distal end 3060 of manipulator61 into the cardiac tissue in a direction parallel to centrallongitudinal axis 3062.

In an embodiment of the present invention, anchor deployment manipulator61 comprises an outer tube 3066 and an anchor driver 36 which is atleast partially positioned within tube 3066. Anchor driver 36 comprisesan elongated, flexible shaft 3070, having at its distal end a driverhead 3072. Rotation of the anchor driver screws the anchors into thecardiac tissue. Each of anchors 32 is shaped so as to define a couplinghead 74 and a tissue coupling element 76. The anchors are typicallyrigid. Tissue coupling elements 76 may, for example, be helical orspiral in shape (e.g., having the shape of a corkscrew), as shown in thefigures, may comprises screws, or may have other shapes. Coupling heads74 may be either male (e.g., a hex or square protrusion) or female(e.g., a straight slot, a hex opening, a Phillips opening, or aRobertson opening). The use of helical anchors, which are screwed intothe cardiac tissue, generally minimizes the force that needs to beapplied during deployment of the anchors into the cardiac tissue.Alternatively, the anchors may comprise staples, clips, spring-loadedanchors, or other tissue anchors described in the referencesincorporated hereinabove in the Background section, or otherwise knownin the art. For some applications, outer tube 3066 of deploymentmanipulator 61 is steerable, as known in the catheter art, while forother applications, a separate steerable tube is provided, as describedhereinbelow with reference to FIG. 10 or FIG. 11. To provide steeringfunctionality to deployment manipulator, outer tube 3066, steerable tube360 (FIG. 10), or steerable tube 362 (FIG. 11), as the case may be,typically comprises one or more steering wires, the pulling andreleasing of which cause deflection of the distal tip of the tube.

In an embodiment of the present invention, each of tissue couplingelements 76 is shaped so as to define a longitudinal axis 78 (shown inFIGS. 1A-B), and is configured to penetrate the cardiac tissue in adirection parallel to longitudinal axis 78. Deployment manipulator 61 isconfigured to deploy tissue coupling element 76 from distal end 3060 ofthe manipulator through the wall of sleeve 26 in a direction parallel tolongitudinal axis 78 and parallel to central longitudinal axis 3062through distal end 3060 of deployment manipulator 61 (shown in FIGS. 2,3, and 7-10).

For some applications, the plurality of anchors are applied using themanipulator by loading a first one of the anchors onto the anchordriver, and deploying the anchor into the cardiac tissue. The anchordriver is withdrawn from the subject's body (typically while leavingouter tube 3066 of the deployment manipulator in place in the sleeve),and a second one of the anchors is loaded onto the anchor driver. Theanchor driver is reintroduced into the outer tube of the manipulator,and the second anchor is deployed. These steps are repeated until all ofthe anchors have been deployed. Alternatively, the entire deploymentmanipulator, including the anchor driver, is removed from the body andsubsequently reintroduced after being provided with another anchor.Further alternatively, the deployment manipulator is configured tosimultaneously hold a plurality of anchors, and to deploy them one at atime (configuration not shown).

Typically, the first anchor 32 is deployed most distally in sleeve 26(generally at or within a few millimeters of a distal end 51 of thesleeve), and each subsequent anchor is deployed more proximally, suchthat manipulator 61 is gradually withdrawn in a proximal directionduring the anchoring procedure.

Reference is now made to FIGS. 5A-B, which are schematic illustrationsof screwdriver tool 80 being used to rotate spool 46 of adjustmentmechanism 40 of ring 3022, in accordance with some applications of thepresent invention. Screwdriver tool 80 has a head 82 that is either male(e.g., comprising a screwdriver head, having, such as a slot-head, anAllen-head, a Phillips-head, a Robertson-head, or a hex-head) or female(e.g., comprising a wrench head, having, for example, a square or hexopening), as appropriate for the driving interface provided. Typically,the screwdriver tool comprises a shaft 84, at least a portion of whichis flexible. For some applications, the screwdriver tool is used that isdescribed in above-referenced U.S. patent application Ser. No.12/341,960 (which published as US 2010/0161047, issued as U.S. Pat. No.8,241,351, and which is incorporated herein by reference), withreference to FIG. 4 thereof. Alternatively, anchor driver 36 ofdeployment manipulator 61 serves as screwdriver tool 80, and is used torotate the spool, in which case driving interface 48 is appropriatelyshaped to receive driver head 3072 of anchor driver 36.

In the configuration shown in FIG. 5A, contracting member 226 is coupledto distal end 51 of sleeve 26, as shown hereinabove in FIGS. 1A and 3.Adjustment mechanism 40 is oriented such that driving interface 48thereof is accessible from within sleeve 26. Screwdriver tool 80 isinserted into sleeve 26, and used to rotate spool 46 via the drivinginterface. Alternatively, anchor driver 36 of deployment manipulator 61serves as screwdriver tool 80, and is used to rotate the spool, in whichcase driving interface 48 is appropriately shaped to engage driver head3072 of anchor driver 36. In either case, the sleeve thus serves toguide the screwdriver tool to driving interface 48. For someapplications, an interior surface of the sleeve is tapered near thedistal end of the sleeve, to help guide the screwdriver head to thedriving interface. For some applications, during the implantationprocedure, anchor deployment manipulator 61 is left slightly insertedinto proximal end 49 of sleeve 26 after all of anchors 32 have beendeployed, in order to facilitate passage of screwdriver tool 80 intosleeve 26.

In the configuration shown in FIG. 5B, access to driving interface 48 isprovided from outside sleeve 26. For some applications, adjustmentmechanism 40 comprises a wire 86 that is attached to the mechanism andpasses out of the body of the subject, typically via sheath 2104. Inorder to readily bring the screwdriver tool to driving interface 48,screwdriver tool 80 is guided over (as shown) the wire, or alongside thewire (configuration not shown).

For some applications, adjustment mechanism 40 is positioned in avicinity of (e.g., within 1 cm of) distal end 51 of sleeve 26, andaccess to driving interface 48 is provided from outside sleeve 26, asdescribed with reference to FIG. 5B (in which the adjustment mechanismis positioned in a vicinity of proximal end 49 of the sleeve).

For some applications in which access to driving interface 48 isprovided from outside sleeve 26, the screwdriver tool is initiallyremovably attached to the driving interface, prior to the commencementof the implantation procedure, and is subsequently decoupled from thedriving interface after spool 46 has been rotated. In theseapplications, adjustment mechanism 40 may be positioned in a vicinity ofdistal end 51 or proximal end 49 of sleeve 26, or at an intermediatelocation along the sleeve. Optionally, at least a portion of a shaft ofthe screwdriver tool is positioned within sheath 2104, which isdescribed hereinbelow with reference to FIGS. 6A-I.

Reference is now made to FIGS. 6A-I, which are schematic illustrationsof a procedure for implanting annuloplasty ring 3022 to repair a mitralvalve 230, in accordance with some applications of the presentinvention. The procedure is typically performed with the aid of imaging,such as fluoroscopy, transesophageal echo, and/or echocardiography.

The procedure typically begins by advancing a semi-rigid guidewire 202into a right atrium 220 of the patient, as shown in FIG. 6A.

As show in FIG. 6B, guidewire 202 provides a guide for the subsequentadvancement of a sheath 2104 therealong and into the right atrium. Oncesheath 2104 has entered the right atrium, guidewire 202 is retractedfrom the patient's body. Sheath 2104 typically comprises a 14-20 Fsheath, although the size may be selected as appropriate for a givenpatient. Sheath 2104 is advanced through vasculature into the rightatrium using a suitable point of origin typically determined for a givenpatient. For example:

-   -   sheath 2104 may be introduced into the femoral vein of the        patient, through an inferior vena cava 223, into right atrium        220, and into a left atrium 224 transseptally, typically through        the fossa ovalis;    -   sheath 2104 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into right atrium        220, and into left atrium 224 transseptally, typically through        the fossa ovalis; or    -   sheath 2104 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into        right atrium 220, and into left atrium 224 transseptally,        typically through the fossa ovalis.

In an embodiment of the present invention, sheath 2104 is advancedthrough an inferior vena cava 223 of the patient (as shown) and intoright atrium 220 using a suitable point of origin typically determinedfor a given patient.

Sheath 2104 is advanced distally until the sheath reaches theinteratrial septum.

As shown in FIG. 6D, a resilient needle 206 and a dilator (not shown)are advanced through sheath 2104 and into the heart. In order to advancesheath 2104 transseptally into left atrium 224, the dilator is advancedto the septum, and needle 206 is pushed from within the dilator and isallowed to puncture the septum to create an opening that facilitatespassage of the dilator and subsequently sheath 2104 therethrough andinto left atrium 224. The dilator is passed through the hole in theseptum created by the needle. Typically, the dilator is shaped to definea hollow shaft for passage along needle 206, and the hollow shaft isshaped to define a tapered distal end. This tapered distal end is firstadvanced through the hole created by needle 206. The hole is enlargedwhen the gradually increasing diameter of the distal end of the dilatoris pushed through the hole in the septum.

The advancement of sheath 2104 through the septum and into the leftatrium is followed by the extraction of the dilator and needle 206 fromwithin sheath 2104, as shown in FIG. 6E.

As shown in FIG. 6F, annuloplasty ring 3022 (with anchor deploymentmanipulator 61 therein) is advanced through sheath 2104 into left atrium224.

As shown in FIG. 6G, distal end 51 of sleeve 26 is positioned in avicinity of a left fibrous trigone 242 of an annulus 240 of mitral valve230. (It is noted that for clarity of illustration, distal end 51 ofsleeve 26 is shown schematically in the cross-sectional view of theheart, although left trigone 242 is in reality not located in the showncross-sectional plane, but rather out of the page closer to the viewer.)Alternatively, the tip is positioned in a vicinity of a right fibroustrigone 244 of the mitral valve (configuration not shown). Furtheralternatively, the distal tip of the sleeve is not positioned in thevicinity of either of the trigones, but is instead positioned elsewherein a vicinity of the mitral valve, such as in a vicinity of the anterioror posterior commissure. For some applications, outer tube 3066 ofanchor deployment manipulator 61 is steerable, as is known in thecatheter art, while for other applications, a separate steerable tube isprovided, as described hereinbelow with reference to FIG. 10 and FIG.11. In either case, the steering functionality typically allows the areanear the distal end of the manipulator to be positioned with six degreesof freedom. Once positioned at the desired site near the selectedtrigone, manipulator 61 deploys a first anchor 32 through the wall ofsleeve 26 into cardiac tissue near the trigone.

As shown in FIG. 6H, deployment manipulator 61 is repositioned alongannulus 240 to another site selected for deployment of a second anchor32. Typically, the first anchor is deployed most distally in the sleeve(generally at or within a few millimeters of the distal tip of thesleeve), and each subsequent anchor is deployed more proximally, suchthat the manipulator is gradually withdrawn in a proximal directionduring the anchoring procedure. The already-deployed first anchor 32holds the anchored end of sleeve 26 in place, so that the sleeve isdrawn from the site of the first anchor towards the site of the secondanchor. Deployment manipulator 61 deploys the second anchor through thewall of the sleeve into cardiac tissue at the second site. Depending onthe tension applied between the first and second anchor sites, theportion of sleeve 26 therebetween may remain tubular in shape, or maybecome flattened, which may help reduce any interference of the ringwith blood flow.

For some applications, in order to provide the second and subsequentanchors, anchor driver 36 is withdrawn from the subject's body viasheath 2104 (typically while leaving outer tube 3066 of the deploymentmanipulator in place in the sleeve), provided with an additional anchor,and then reintroduced into the subject's body and into the outer tube.Alternatively, the entire deployment manipulator, including the anchordriver, is removed from the body and subsequently reintroduced uponbeing provided with another anchor. Further alternatively, deploymentmanipulator 61 is configured to simultaneously hold a plurality ofanchors, and to deploy them one at a time at the selected sites.

As shown in FIG. 6I, the deployment manipulator is repositioned alongthe annulus to additional sites, at which respective anchors aredeployed, until the last anchor is deployed in a vicinity of rightfibrous trigone 244 (or left fibrous trigone 242 if the anchoring beganat the right trigone). Alternatively, the last anchor is not deployed inthe vicinity of a trigone, but is instead deployed elsewhere in avicinity of the mitral valve, such as in a vicinity of the anterior orposterior commissure.

As described hereinabove with reference to FIGS. 1A and 1B, ascrewdriver tool or anchor driver 36 of deployment manipulator 61 isused to rotate spool 46 of adjustment mechanism 40, in order to tightenring 3022. (For clarity of illustration, contracting member 226 of ring3022, although provided, is not shown in FIGS. 6A-I.) Alternatively,another technique is used to tighten the ring, such as describedhereinabove.

For some applications, sleeve 26 is filled with a material (e.g.,polyester, polytetrafluoroethylene (PTFE), polyethylene terephthalate(PET), or expanded polytetrafluoroethylene (ePTFE)) after beingimplanted. The material is packed within at least a portion, e.g., 50%,75%, or 100%, of the lumen of sleeve 26. The filler material functionsto prevent (1) formation within the lumen of sleeve 26 of clots or (2)introduction of foreign material into the lumen which could obstruct thesliding movement of contracting member 226.

For some applications, proximal end 49 of sleeve 26 is closed uponcompletion of the implantation procedure. Alternatively, the proximalend of the sleeve may have a natural tendency to close when not heldopen by manipulator 61.

Reference is made to FIG. 7, which is a schematic illustration of thedeployment of one of anchors 32 into cardiac tissue, in accordance withsome applications of the present invention. In this embodiment, one ormore (such as all) of anchors 32 are deployed from left atrium 224,through tissue of the atrial wall, and into tissue of an upper region ofthe ventricular wall 150 near the atrium. Because the tissue of theupper region of ventricular wall is thicker than that of the atrialwall, deploying the anchors into the upper region of the ventricularwall generally provides more secure anchoring. In addition, because theanchors are not deployed laterally through the atrial wall, the risk ofperforating the atrial wall is reduced.

Annuloplasty ring 3022 may be advanced toward annulus 240 in anysuitable procedure, e.g., a transcatheter procedure, a minimallyinvasive procedure, or an open heart procedure (in which case one ormore elements of system 10 are typically rigid). Regardless of theapproach, the procedure typically includes the techniques describedhereinabove with reference to FIGS. 6G-I and 7.

For some applications, following initial contraction of annuloplastyring 3022 during the implantation procedure, the ring may be furthercontracted or relaxed at a later time after the initial implantation.Using real-time monitoring, tactile feedback and optionally incombination with fluoroscopic imaging, a screwdriver tool or anchordriver 36 of deployment manipulator 61 is reintroduced into the heartand used to contract or relax annuloplasty ring 3022.

Reference is now made to FIG. 8, which is a schematic illustration ofsystem 10 comprising a flexible pusher element 200, in accordance withsome applications of the present invention. Pusher element 200 aids withaccurately positioning successive anchors 32 during an implantationprocedure, such as described hereinabove with reference to FIGS. 6H and61. For some applications, pusher element 200 is positioned partiallywithin tube 3066 of deployment manipulator 61 such that a distal portion204 of pusher element 200 extends distally out of tube 3066, through anopening 208 in a vicinity of a distal end of the tube (e.g., that iswithin 3 mm of the distal end, such as within 2 mm of the distal end). Aproximal portion of pusher element 200 passes through outer tube 3066from opening 208 to the proximal end of tube 3066. Opening 208 isprovided either through a wall of the tube (as shown in FIG. 8), orthrough the distal end of the tube (configuration not shown).Alternatively, pusher element 200 is positioned within sleeve 26, butoutside of tube 3066 (configuration not shown). Typically, the pusherelement is elongated, and is at least as long as sleeve 26.

Pusher element 200 helps move the distal end of deployment manipulator61 from a first site of the annulus at which the manipulator has alreadydeployed a first anchor (e.g., anchor 32A in FIG. 8) to a second sitefor deployment of a second anchor (e.g., anchor 32B), in a directionindicated schematically by an arrow 211. Pusher element 200 is pusheddistally out of opening 208 of tube 3066, so that a distal end 212 ofpusher element 200 engages and pushes against an interior surface ofsleeve 26, in a direction indicated schematically by an arrow 214. Theinterior surface of the sleeve may be distal end 51 of the sleeve (asshown), or the wall of the sleeve at a location between distal end 51and opening 208 (not shown). As a result, the distal end of manipulator61 moves in the opposite direction, i.e., as indicated by arrow 211,toward a subsequent anchoring site. The movement in the direction ofarrow 211 is generally along a line or curve defined by the portion ofpusher element 200 already extended between the anchors that havealready been deployed.

For some applications, as manipulator 61 is positioned at successivedeployment sites of the cardiac tissue, pusher element 200 is extendedrespective distances through opening 208, each of which distances issuccessively greater. For other applications, after manipulator 61 ispositioned at each successive deployment site, the pusher element ispulled back in a proximal direction, and again extended a desireddistance in a distal direction, such that the pusher element pushesagain the wall of the sleeve (at a different location on the wall foreach successive relocation of manipulator 61).

This technique thus aids in locating each subsequent anchoring site formanipulator 61. The pusher element may also help control the distancebetween adjacent anchoring sites, because they surgeon may push thepusher element a known distance after deploying each anchor.

Pusher element 200 typically comprises a strip, wire, ribbon, or band,and has a cross-section that is circular, elliptical, or rectangular.Pusher element 200 typically comprises a flexible and/or superelasticmaterial, such as a metal such as nitinol, stainless steel, or cobaltchrome. Distal end 212 of pusher element 200 is dull, so that it doesnot penetrate sleeve 26. For example, the distal end may be folded back,as shown in FIG. 8.

FIG. 9 is a schematic illustration of a pusher tube 250 applied toproximal end 49 of sleeve 26, in accordance with some applications ofthe present invention. Pusher tube 250 pushes gently in a distaldirection on proximal end 49 of sleeve 26. For example, if, duringwithdrawal of outer tube 3066 in a proximal direction, the outer tubesnags on the wall of sleeve 26 (which, as mentioned above, may comprisebraided or woven fabric), such pushing may help free the snag. For someapplications, the techniques of this embodiment are practiced incombination with those of the embodiment described hereinbelow withreference to FIG. 12. (Although in the embodiment described withreference to FIG. 9, system 10 typically comprises contracting member226, for clarity of illustration the contracting member is not shown inthe figure.)

FIG. 10 is a schematic illustration of system 10 comprising a steerabletube 360, in accordance with some applications of the present invention.In this embodiment, outer tube 3066 of deployment manipulator 61 is notsteerable. Instead, to provide steering functionality, deploymentmanipulator 61 comprises a separate steering tube 360, which ispositioned around at least a portion of outer tube 3066. Outer tube3066, because it does not provide this steering functionality, may havea smaller diameter than in the embodiment described hereinabove withreference to FIG. 3. Because outer tube 3066 has a smaller diameter,sleeve 26 may also have a smaller diameter than in the embodimentdescribed hereinabove with reference to FIG. 3. For some applications,the techniques of this embodiment are practiced in combination withthose of the embodiment described hereinabove with reference to FIG. 9.(Although in the embodiment described with reference to FIG. 10, system10 typically comprises contracting member 226, for clarity ofillustration the contracting member is not shown in the figure.)

FIG. 11 is a schematic illustration of system 10 comprising a steerabletube 362, in accordance with some applications of the present invention.In this embodiment, outer tube 3066 of deployment manipulator 61 is notsteerable. Steering functionality is instead provided by separatesteering tube 362, which is positioned around at least a portion ofshaft 3070 of anchor driver 36, and within outer tube 3066. For someapplications, the techniques of this embodiment are practiced incombination with those of the embodiment described hereinabove withreference to FIG. 9. (Although in the embodiment described withreference to FIG. 11, system 10 typically comprises contracting member226, for clarity of illustration the contracting member is not shown inthe figure.)

FIG. 12 is a schematic illustration of system 10 comprising a pullingwire 3340, in accordance with some applications of the presentinvention. A distal portion 3342 of pulling wire 3340 is coupled toproximal end 49 of sleeve 26, such as by passing through one or moreholes near the proximal end. One or more proximal portions 3344 of thepulling wire are coupled to an external control handle 3346 of system10, which is manipulated by the surgeon outside of the subject's body.Optionally, a portion of deployment manipulator 61 (e.g., a portion ofouter tube 3066) which is never inserted in sleeve 26 comprises one ormore coupling elements 3348, such as loops or tubes, through whichpulling wire 3340 passes in order to hold the pulling wire close to theexternal surface of the deployment manipulator.

Pulling wire 3340 holds sleeve 26 surrounding deployment manipulator 61.As the pulling wire is released in a distal direction as deploymentmanipulator 61 is withdrawn in a proximal direction, the release of thesleeve allows the sleeve to gradually be removed from around thedeployment manipulator. In FIG. 12, the sleeve is shown partiallyremoved from the manipulator, including the portion of the sleevethrough which one of anchors 32 has been deployed.

For some applications, control handle 3346 is configured to releasepulling wire 3340 incrementally, such that each time the wire is furtherreleased by a set distance. As a result, the deployment manipulator iswithdrawn from the sleeve by this set distance, andsubsequently-deployed anchors are approximately this set distance apartfrom one another. For example, the handle may comprise a control ring3350 that is coupled to proximal portions 3344 of the wire, andremovably engages slots 3352 on the handle that are spaced apart by thisset distance. Upon completion of the implantation procedure, in order todetach the pulling wire from the sleeve, one end of the wire may be cutor released, and the wire detached from the sleeve by pulling on theother end of the wire.

(Although in the embodiment described with reference to FIG. 12, system10 typically comprises contracting member 226, for clarity ofillustration the contracting member is not shown in the figure.)

Reference is now made to FIGS. 13-14, which are schematic illustrationsof a multi-component tubular system 10 providing one or morerotationally-controlled steering catheters configured for delivering animplant to a heart of a patient, in accordance with some applications ofthe present invention. System 10 provides an implant-delivery tool.Typically, system 10 comprises a first, outer catheter 12 comprising asheath configured for advancement through vasculature of a patient. Forsome applications of the present invention, outer catheter 12 comprisesa sheath configured for advancement through a femoral artery toward aninteratrial septum of a heart of a patient. A distal steerable endportion of outer catheter 12 is configured to pass through the septumand be oriented in a desired spatial orientation. System 10 comprises asecond catheter, or guide catheter 14, comprising a steerable distal endportion. Catheter 14 is configured for advancement through a lumen ofouter catheter 12. Outer catheter 12 provides a first coupling 152(e.g., a slit 52) at a distal portion thereof (e.g., a portion ofcatheter 12 that is proximal to the steerable distal end portion). Guidecatheter 14 comprises a second coupling 154 (e.g., a depressible engager54 comprising a detent) that is coupled to a displaceable tab 56 coupledto a base. As is described herein, depressible engager 54 (or the secondcoupling 154) is configured so as to protrude within slit 52 (or thefirst coupling 152). Thus, slit 52 defines a second-coupling-receivingelement.

First coupling 152 of catheter 12 defines a longer coupling, the secondcoupling 154 of catheter 14 defines a shorter coupling. The first andsecond couplings 152 and 154 of outer catheter 12 and guide catheter 14,respectively, enable axial advancement and rotational motion of guidecatheter 14 through the lumen of outer catheter 12 until engager 54 ofcatheter 14 is aligned with and engages slit 52 of catheter 12, as willbe described hereinbelow. As shown in cross-section A-A of FIG. 13,guide catheter 14 is configured to be concentrically disposed within alumen of outer catheter 12. It is to be noted that the scope of thepresent invention includes catheter 12 providing the shorter coupling,and catheter 14 providing the longer coupling. For example, catheter 14may be shaped so as to provide slit 52, and catheter 12 may compriseengager 54, which is configured to engage slit 52 of catheter 14.

As shown in the exploded view of view B, first coupling 152 is shaped soas to define slit 52. For some applications, slit 52 is provided by ametal frame 50, as shown. Metal frame 50 has a length L22 of between 7and 15 mm, e.g., 13 mm. For such applications, a slit is created inmaterial of catheter 12 (e.g., by creating a slit in the polymermaterial of catheter 12 during manufacturing of catheter 12), and frame50 is coupled to catheter 12. Second coupling 154 comprises an engager54 which comprises a protrusion disposed at a distal portion ofdisplaceable tab 56 of a base of engager 54. The base of engager 54 isshaped so as to define slits 57 which form tab 56. Engager 54 isdepressible when a force is applied thereto, and tab 56 facilitatesmovement of engager 54 in response to and in the absence of forceapplied to engager 54. For some applications, during manufacture ofcatheter 14, catheter 14 is manipulated in order to couple theretoengager 54 and tabs 56, e.g., engager 54 and tabs 56 are embedded withinthe polymer of catheter 14.

It is to be noted that although slit 52 and depressible engager 54 areshown on outer catheter 12 and guide catheter 14, respectively, atdistal portions of catheters 12 and 14, slit 52 and engager 54 may beprovided along any suitable portion of catheters 12 and 14, respectively(e.g., a respective proximal portions of catheters 12 and 14).

FIG. 14 shows the concentric relationship between components of tubularsystem 10 (in an exploded view on the left side of FIG. 14). Asdescribed hereinabove, a distal end portion of outer catheter 12 issteerable. The distal end portion of outer catheter 12 comprises a pullring 11 that is coupled to two or more pull wires 29 a and 29 b, thatare disposed within respective secondary lumens within a wall ofcatheter 12 (as shown in section A-A). As shown in the exploded view,guide catheter 14 is configured to be concentrically disposed within thelumen of catheter 12. As described hereinabove, the distal end portionof guide catheter 14 is steerable. The distal end portion of catheter 14comprises a pull ring 13 that is coupled to two or more pull wires 31 aand 31 b, that are disposed within respective secondary lumens within awall of catheter 14 (as shown in sections A-A and B-B).

Guide catheter 14 is steerable to a desired spatial orientation in orderto facilitate advancing and implantation of an implant in a body cavityof the patient. As shown, the implant comprises an annuloplasty ringstructure 222 which defines a longitudinal implant comprising a flexiblesleeve 26 (shown in the exploded view of FIG. 14). Sleeve 26 typicallycomprises a braided fabric mesh, e.g., comprising DACRON™. Sleeve 26 istypically configured to be placed only partially around a cardiac valveannulus (i.e., to assume a C-shape), and, once anchored in place, to becontracted so as to circumferentially tighten the valve annulus.Alternatively, the ring structure is configured to be placed entirelyaround the valve annulus. In order to tighten the annulus, annuloplastyring structure 222 comprises a flexible elongated contracting member 226that extends along sleeve 26. Elongated contracting member 226 comprisesa wire, a ribbon, a rope, or a band, which typically comprises aflexible and/or superelastic material, e.g., nitinol, polyester,stainless steel, or cobalt chrome. For some applications, the wirecomprises a radiopaque material. For some applications, contractingmember 226 comprises a braided polyester suture (e.g., Ticron). For someapplications, contracting member 226 is coated withpolytetrafluoroethylene (PTFE). For some applications, contractingmember 226 comprises a plurality of wires that are intertwined to form arope structure.

For applications in which system 10 is used to deliver an implant to themitral valve of the patient, typically, outer catheter 12 is configuredfor initial advancement through vasculature of the patient until adistal end 102 of catheter 12 is positioned in the left atrium. Thedistal steerable end portion of catheter 12 is then steered such thatdistal end 102 of catheter 12 is positioned in a desired spatialorientation within the left atrium. The steering procedure is typicallyperformed with the aid of imaging, such as fluoroscopy, transesophagealecho, and/or echocardiography. Following the steering of the distal endportion of catheter 12, guide catheter 14 (which houses annuloplastyring structure 222) is advanced through catheter 12 in order tofacilitate delivery and implantation of structure 222 along the annulusof the mitral valve. During the delivery, at least a portion of thesteerable distal end portion of catheter 14 is exposed from distal end102 of catheter 12 and is thus free for steering toward the annulus ofthe mitral valve, as is described hereinbelow.

Annuloplasty ring structure 222 further comprises an adjustmentmechanism 40, which facilitates contracting and expanding ofannuloplasty ring structure 222 so as to facilitate adjusting of aperimeter of the annulus and leaflets of the cardiac valve. Adjustmentmechanism 40 is described in more detail hereinbelow. Adjustmentmechanism 40 comprises a rotatable structure (e.g., a spool, asdescribed hereinbelow) that is disposed within a housing 44. As shown inthe enlarged image of FIG. 1, adjustment mechanism 40 is surrounded by abraided mesh and is coupled (e.g., by being sutured or otherwisecoupled) to the braided mesh of sleeve 26. For some applications,adjustment mechanism 40 is coupled to an outer, lateral surface ofsleeve 26. During delivery of sleeve 26 to the annulus of the cardiacvalve, sleeve 26 and mechanism 40 are disposed within a lumen ofcatheter 14 and are aligned longitudinally with a longitudinal lumen ofcatheter 14. Such coupling of mechanism 40 to sleeve 26 allows mechanism40 to transition from a state in which it is in line with thelongitudinal axis of catheter 14 (FIG. 14) to a state in which it isdisposed alongside sleeve 26 (FIG. 13). The positioning of adjustmentmechanism 40 alongside a portion of sleeve 26 exposes a drivinginterface of the rotational structure to be accessed by a rotationaltool that is guided toward adjustment mechanism 40 via a guide member86.

A flexible, longitudinal guide member 86 (e.g., a wire) is coupled to aportion of adjustment mechanism 40 (e.g., a portion of the rotatablestructure, as described hereinbelow). Guide member 86 is configured tofacilitate guiding of a rotational tool via guide member 86 and towardthe rotatable structure of adjustment mechanism 40. Typically, therotational tool is configured to engage the rotatable structure ofadjustment mechanism 40 following implantation of sleeve 26 along theannulus of the cardiac valve. Guide member 86 passes from adjustmentmechanism 40, alongside a portion of the distal end portion of guidecatheter 14, and into a secondary lumen in the wall of guide catheter14, through an opening 15 in guide catheter 14. Guide member 86 passesthrough the secondary lumen of guide catheter 14 (as shown in sectionsA-A and B-B in FIG. 14) and has a proximal end that is accessible fromoutside the body of the patient. The secondary lumen in the wall ofguide catheter 14 facilitates passage of guide member 86 through system10 without interfering with the other concentrically-disposed elongatetubular members that pass concentrically through the lumen of guidecatheter 14.

In addition, system 10 comprises a plurality of anchors 32, typicallybetween about 5 and about 20 anchors, such as about 10 or about 16anchors. Each anchor 32 comprises a tissue coupling element 60 (e.g., ahelical tissue coupling element), and a tool-engaging head 62, fixed toone end of the tissue coupling element. Only one anchor 32 is shown inFIG. 14 as being reversibly coupled to a deployment element 38 of arotating anchor driver 36 of an anchor deployment manipulator 61. Whensleeve 26 is disposed along the annulus of the cardiac valve, deploymentmanipulator 61 is configured to advance within a lumen of sleeve 26 anddeploy each anchor 32 from within sleeve 26 through a wall of sleeve 26and into cardiac tissue, thereby anchoring sleeve 26 around a portion ofthe valve annulus. The insertion of the anchors into the sleeve anddeployment of the anchors into cardiac tissue is described in detailhereinbelow.

Typically, but not necessarily, anchors 32 comprise a biocompatiblematerial such as stainless steel 316 LVM. For some applications, anchors32 comprise nitinol. For some applications, anchors 32 are coated fullyor partially with a non-conductive material.

As shown in the exploded view of FIG. 14, sleeve 26 is disposed within alumen of guide catheter 14. A force is applied to a proximal end ofsleeve 26 is by a distal end of a reference-force tube 19. As shown, animplant-decoupling channel 18 is advanceable within a lumen ofreference-force tube 19 and through a lumen of sleeve 26. As shown inthe enlarged image of FIG. 13, a distal end 17 of implant-decouplingchannel 18 is disposed in contact with an inner wall of sleeve 26 at adistal end thereof. Additionally, a distal end portion of channel 18comprises a radiopaque marker 1018. As shown, tube 19 and sleeve 26 arelongitudinally and coaxially disposed with respect to each other.

For some applications, channel 18 is steerable.

Deployment manipulator 61 comprises anchor driver 36 and deploymentelement 38. Additionally, deployment manipulator comprises channel 18.

Reference is now made to FIGS. 14 and 2. It is to be noted thatmanipulator 61 shown in FIG. 2 comprises manipulator 61 as describedherein with respect to FIG. 14.

Typically, manipulator 61 advances within channel 18. For someapplications, system 10 comprises a plurality of anchor drivers 36 ofmanipulator 61, each driver 36 being coupled to a respective anchor 32.Each driver 36 is advanced within channel 18 in order to advance andimplant anchor 32 in tissue. Following implantation of anchor 32, anchor32 is decoupled from driver 36, as described herein, and driver 36 isremoved from within channel 18. Subsequently, a new driver 36 coupled toanother anchor 32 is then advanced within channel 18.

As will be described hereinbelow, a first anchor 32 is configured to bedeployed through the wall of the sleeve into cardiac tissue, when sleeve26 is positioned along the annulus of the valve. Following thedeployment of the first anchor, a distal portion of sleeve 26 is sliddistally off a portion of implant-decoupling channel 18. In order todecouple sleeve 26 distally from a portion of outer surface of channel18, (1) a proximal force is applied to channel 18, while (2)reference-force tube 19 is maintained in place in a manner in which adistal end of tube 19 provides a reference force to sleeve 26 in orderto facilitate freeing of a successive portion of sleeve 26 from aroundchannel 18. Channel 18 is then positioned at a successive locationwithin the lumen of sleeve 26 while either tube 19 and/or catheter 14 issteered toward a successive location along the annulus of the valve (aswill be described hereinbelow). Consequently, the successive portion ofsleeve 26 provides a free lumen for advancement of a successive anchor32 and deployment of the anchor through the wall of the sleeve at thesuccessive portion thereof. Such freeing of the successive portion ofsleeve 26 creates a distance between successive anchors deployed fromwithin the lumen of sleeve 26.

For some applications, sleeve 26 comprises a plurality of radiopaquemarkers 25, which are positioned along the sleeve at respectivelongitudinal sites. The markers may provide an indication in aradiographic image (such as a fluoroscopy image) of how much of thesleeve has been deployed at any given point during an implantationprocedure, in order to enable setting a desired distance between anchors32 along the sleeve. For some applications, the markers comprise aradiopaque ink.

Typically, at least a portion (e.g., at least three, such as all) of thelongitudinal sites are longitudinally spaced at a constant interval.Typically, the longitudinal distance between the distal edges ofadjacent markers, and/or the distance between the proximal edges ofadjacent markers, is set equal to the desired distance between adjacentanchors. For example, the markers may comprise first, second, and thirdmarkers, which first and second markers are adjacent, and which secondand third markers are adjacent, and the distance between the proximaland/or distal edges of the first and second markers equal thecorresponding distance between the proximal and/or distal edges of thesecond and third markers. For example, the distance may be between 3 and15 mm, such as 6 mm, and the longitudinal length of each marker may bebetween 0.1 and 14 mm, such as 2 mm. (If, for example, the distance were6 mm and the length were 2 mm, the longitudinal gaps between adjacentmarkers would have lengths of 4 mm.)

Each anchor 32 is coupled to deployment element 38 of anchor driver 36.Anchor driver 36 comprises an elongate tube having at least a flexibledistal end portion. The elongate tube of driver 36 extends within alumen of channel 18, through system 10 toward a proximal end of aproximal handle portion 101 of system 10, which defines a proximalextracorporeal portion of the apparatus. The tube of anchor driver 36provides a lumen for slidable advancement therethrough of an elongaterod 130. Rod 130 facilitates the locking and unlocking of anchor 32 todeployment element 38, as is described hereinbelow. As shown in SectionE-E of FIG. 14, a proximal end of rod 130 is coupled to a component ofan anchor-release mechanism 28 at a proximal end of system 10. Mechanism28 comprises a housing 135 and a finger-engager 131 that is coupled tothe proximal end of rod 130. Finger-engager 131 is coupled to a housing135 via a spring 133 (section E-E of FIG. 14). A proximal end of thetube of anchor driver 36 is coupled to housing 135. As is describedhereinbelow, the physician releases anchor 32 from deployment element 38when finger-engager 131 is pulled proximally, thereby pulling rod 130proximally.

Proximal handle portion 101 is supported by a stand having support legs91 and a handle-sliding track 90. Proximal handle portion 101 defines aproximal extracorporeal portion. Handle portion 101 comprises anouter-catheter handle 22, a guide-catheter handle 24, animplant-manipulating handle 126, and anchor-release mechanism 28. Handle22 of the proximal extracorporeal portion of handle portion 101 iscoupled to a proximal end of outer catheter 12 and functions as a firstcontrol mechanism to control catheter 12. Handle 24 of the proximalextracorporeal portion of handle portion 101 is coupled to a proximalportion of guide catheter 14 and functions as a second control mechanismto control catheter 14. Handle 126 is coupled to a proximal portion ofreference-force tube 19, and linear movement of handle 126 with respectto handle 24 moves reference-force tube 19 (and thereby typicallystructure 222) through catheter 14. As described hereinabove, housing135 of anchor-release mechanism 28 is coupled to a proximal portion ofthe tube of anchor driver 36. The relative positioning of each of theconcentrically-disposed components of system 10 is shown in the explodedview and sections A-A, B-B, C-C, and D-D of FIG. 14.

The stand supporting proximal handle portion 101 may be moved distallyand proximally to control a position of the entire multi-componentsystem 10, particularly so as to adjust a distance of distal end 102 ofcatheter 12 from the interatrial septum. Handle 22 comprises a steeringknob 210 that is coupled to steering wires 29 a and 29 b disposed withinrespective secondary lumens in the wall of outer catheter 12. Rotationof knob 210 adjusts a degree of tension of wires 29 a and 29 b which, inturn, apply a force to pull ring 11 at the distal end portion of outercatheter 12. Such force steers the distal end portion of catheter 12within the atrium of the heart of the patient in a manner in which thedistal end portion of catheter 12 is steered in a first plane that isparallel with the plane of the annulus of the valve (e.g., in adirection from the interatrial septum toward surrounding walls of theatrium). For some applications of the present invention, the distal endportion of catheter 12 may be pre-shaped so as to point downward towardthe valve. For other applications, the distal end portion of catheter 12may be pulled to assume an orientation in which the distal end portionpoints downward toward the valve. For yet other applications of thepresent invention, the distal end portion of catheter 12 is not made topoint downward toward the valve.

Handle 24 is coupled to track 90 via a first mount 92. Mount 92 isslidable proximally and distally along track 90 in order to control anaxial position of guide catheter 14 with respect to outer catheter 12.Mount 92 is slidable via a control knob 216. For example, control knob216 of mount 92 controls the proximal and distal axial movement of thedistal steerable portion of guide catheter 14 with respect to distal end102 of outer catheter 12. Handle 24 comprises a steering knob 214 thatis coupled to steering wires 31 a and 31 b disposed within respectivesecondary lumens in the wall of guide catheter 14. Rotation of knob 214adjusts a degree of tension of wires 31 a and 31 b which, in turn, applya force to pull ring 13 at the distal end portion of guide catheter 14.Such force steers the distal end portion of catheter 14 in a secondplane within the atrium of the heart of the patient downward and towardthe annulus of the cardiac valve. Typically, as described hereinbelow,the distal end portion of guide catheter 14 is steered in the secondplane that is substantially perpendicular with respect to the firstplane in which the distal end portion of outer catheter 12 is steered.

The combined steering of the respective distal end portions of catheters12 and 14 directs sleeve 26 down toward the annulus (e.g., via thesteering of the distal end portion of catheter 14) and along theperimeter of annulus (e.g., from the posterior section of the valve tothe anterior section of the valve, and vice versa), via the steering ofthe distal end portion of catheter 12.

For some applications, handle 22 may be tilted by the operatingphysician, in order to further adjust a position of the distal end ofcatheter 12.

As described herein, first and second couplings 152 and 154 of outercatheter 12 and guide catheter 14, respectively (e.g., slit 52 andengager 54, respectively), provide a controlled steerable system inwhich, during the steering and bending of the distal end portion ofguide catheter 14, the distal end portion of outer catheter 12 ismaintained in its steered configuration, or in its spatial orientation,without substantially affecting the steering or the bending of thedistal end portion of guide catheter 14. Thus, first and secondcouplings 152 and 154, respectively, minimize the effect of the distalend portion of outer catheter 12 on the steering and bending of catheter14. That is, first and second couplings 152 and 154 of outer catheter 12and guide catheter 14, respectively, collectively define arelative-spatial-orientation-controlling device which rotationally locksthe relative spatial orientation of the steerable distal end portion andthe bending section of outer catheter 12 with respect to the steerabledistal end portion and the bending section of guide catheter 14.

Guide member 86 exits from the lumen in the wall of guide catheter 14 ata portion of handle portion 101 that is between handles 22 and 24.

Handle 126 is coupled to track 90 via a second mount 93. Mount 93 isslidable proximally and distally along track 90, in order to control anaxial position of reference-force tube 19 and at least a proximalportion of sleeve 26 with respect to guide catheter 14. Mount 93 isslidable via a control knob 95. For example, control knob 95 of mount 93controls the proximal and distal axial movement of the tube 19 and atleast the proximal portion of sleeve 26 with respect to distal end 104of guide catheter 14. Taken together with the steering of the distal endportion of guide catheter 14, such movement of tube 19 and at least theproximal portion sleeve 26 moves the proximal portion of sleeve 26toward a desired portion of tissue of the annulus of the valve duringdeployment of anchors 32 from within the lumen of sleeve 26, as isdescribed hereinbelow.

As is described hereinabove, in order to decouple sleeve 26 from aportion of an outer surface of channel 18, (1) channel 18 is pulledproximally, while (2) reference-force tube 19 is maintained in place. Aproximal end of channel 18 is coupled to a knob 94 which adjusts anaxial position of channel 18 proximally and distally with respect toreference-force tube 19 and sleeve 26.

Typically, handle portion 101 comprises a release decision facilitationmember 127, such as a latch or button, that automatically engages when agiven length of sleeve 26 has advanced off channel 18 (e.g., whenchannel 18 is at a given position with respect to tube 19); typicallyjust before sleeve 26 becomes completely decoupled from channel 18.Engagement of member 127 inhibits proximal movement of channel 18 withrespect to tube 19, thereby reducing a likelihood of (e.g., preventing)inadvertent release of sleeve 26. In order to release sleeve 26 (e.g.,to decouple channel 18 from the sleeve), the operating physician mustdisengage member 127, such as by pushing the button, before continuingto withdraw channel 18 proximally. Typically, when engaged, member 127also inhibits distal movement of channel 18 with respect to tube 19.

Handle portion 101 (comprising handles 22, 24, and 126 andanchor-release mechanism 28) has a length L1 of between 65 and 85 cm,e.g., 76 cm. Typically, as shown, a majority of the body portion ofouter-catheter handle 22 is disposed at a non-zero angle with respect toa longitudinal axis 7 of the multiple components of system 10. Thesteering mechanism provided by handle 22 in order to steer the distalend portion of catheter 12 is disposed within the portion of handle 22that is disposed at the non-zero angle with respect to axis 7. Handle 22comprises an in-line tubular portion 21 which is longitudinally disposedin-line along axis 7 and coaxially with respect to handles 24 and 126and release mechanism 28. Tubular portion 21 is shaped so as to define alumen for inserting guide catheter 14 therethrough and subsequently intothe lumen of outer catheter 12 (as is described hereinbelow withreference to FIG. 15A). Tubular portion 21 has a length L24 of between 7and 11 cm, e.g., 7 cm. Such spatial orientation of the majority ofhandle 22 at an angle with respect to axis 7 reduces an overallfunctional length of handle portion 101.

Reference is now made to FIGS. 15A-E, which are schematic illustrationsof the functional relationship between first and second couplings 152and 154, respectively, and respective degrees of rotational freedom ofguide catheter 14 with respect to outer catheter 12, in accordance withsome applications of the present invention. It is to be noted that FIGS.15A-E show a functional relationship between catheters 12 and 14, and,for clarity of illustration, does not show the concentric componentsdisposed within a longitudinal lumen 59 of catheter 14 (i.e.,reference-force tube 19, channel 18, anchor driver 36, and rod 130, asshown in FIGS. 13 and 14). FIG. 15A shows catheters 12 and 14 in a stateprior to advancing catheter 14 through a lumen 58 of catheter 12.Sections A-A and B-B of FIG. 15A show slit 52, or first coupling 152,empty. Section C-C shows a portion of catheter 14 which provides engager54, or second coupling 154. As described hereinabove with reference toFIG. 13, engager 54 is coupled to a depressible tab 56 which facilitatesdepressible movement of engager 54 when a force is applied thereto(e.g., at a later stage by an inner wall 951 of catheter 12 thatsurrounds lumen 58 when catheter 14 is advanced through lumen 58, as isdescribed hereinbelow). As shown in section C-C of FIG. 15A, in theabsence of a pushing force, tab 56 is disposed in parallel withlongitudinal axis 7, and engager 54 is in a resting state thereof inwhich engager 54 is not in a depressed state and protrudes from anexternal surface of catheter 14.

As shown in sections A-A and B-B of FIGS. 15A-B, first coupling 152 isprovided in a manner in which lumen 58 of catheter 12 is free from anyprotrusions. Additionally, inner wall 951 of catheter 12 is not shapedto define any interrupted portions, such as recessed portions, along aproximal portion of catheter 12 and extending toward distal end 102 ofcatheter 12, except for slit 52 at a distal portion thereof. Oncecatheter 12 is advanced through the vasculature of the patient, distalend 104 of catheter 14 is configured to enter a lumen provided bytubular portion 21 of handle 22, and subsequently, catheter 14 passesthrough lumen 58 of catheter 12. View E is a view of lumen 58 ofcatheter 12 from a proximal portion of tubular portion 21 of handle 22.Since lumen 58 is free from any protrusions or recessed portions, asdescribed hereinabove, and since engager 54 is depressible by tab 56,catheter 14 is configured to enter lumen 58 of catheter 12 in anyrotational configuration thereof. Catheter 14 is shown in section D-D ina manner in which engager is oriented at 12 o'clock, by way ofillustration and not limitation. Catheter 14 may enter lumen 58 ofcatheter 12 in any rotational configuration thereof, therefore, engager54 is shown in phantom in a plurality of orientations in section D-D,since catheter 14 may enter lumen 58 of catheter 12 in a rotationalorientation in which engager 54 may be oriented in any given orientationwith respect to inner wall 951 of catheter 12.

During the insertion of distal end 104 and the distal portion ofcatheter 14, the physician pushes down on engager 54 such that engager54 fits within the lumen of catheter 12. In response to the pushingforce on engager 54, tab 56 is pushed downward as well.

Typically, catheter 12 has an inner diameter (or the diameter of lumen58) of between 6.5 and 7.0 mm (e.g., 6.85 mm). Typically, catheter 14has an inner diameter (or the diameter of lumen 59) of between 4.7 and5.3 mm (e.g., 5.1 mm). System 10, by providing slit 52 and depressibleengager 54, provides a system in which the inner diameters of catheters12 and 14 are maintained during given stages of the procedure. Forexample, engager 54 maintains the inner diameter of catheter 12 ascatheter 14 is advanced within the lumen of catheter 12, and slit 52maintains the inner diameter of catheter 14 once engager 54 pops up andis disposed within slit 52.

FIG. 15B shows the axial advancement of a distal portion of catheter 14through the lumen of catheter 12 in the direction as indicated by arrow1. Typically, the advancement of catheter 14 through catheter 12 iscontrolled by the physician who moves handle 24 axially closer to handle22. During the advancement of catheter 14 through catheter 12, engager54 is maintained in a pushed state (as shown in section A-A of FIG. 15B)by a pushing force applied thereto by inner wall 951 of catheter 12. Asshown in section B-B of FIG. 15B, inner wall 951 of outer catheter 12pushes on engager 54, in the direction as indicated by the radial arrow.In response to the force applied on engager 54 by inner wall 951 ofcatheter 12, engager 54 is pushed and tab 56 is displaced at a non-zeroangle with respect to axis 7 in order to allow for depression of engager54. During the depression of engager 54, engager 54 is pushed slightlywithin lumen 59 of catheter 14.

As described hereinabove, inner wall 951 of catheter 12 is smooth anduninterrupted by recesses or slits (except for slit 52 at the distal endof catheter 12). Typically, slit 52 has a length L2 (shown in view B ofFIG. 13) of between 5 and 15 mm, e.g., 10 mm. A proximal-most end ofslit 52 is disposed up to 100 mm (e.g., up to 60 mm) from distal end 102of catheter 12. Catheter 12 is typically between 80 and 100 cm long.Thus, inner wall 951 of the proximal portion of catheter 12, until theproximal-most end of slit 52, is smooth and uninterrupted by recesses orslits. Taken together, the depressibility of engager 54 and such asmooth configuration of inner wall 951 of catheter 12 enables rotationof catheter 14 by 360 degrees (i.e., as indicated by arrow 2) within thelumen of catheter 12.

FIG. 15C shows further axial advancement of catheter 14 within the lumenof catheter 12. As described hereinabove, during the advancement, andprior to the engaging of engager 54 with slit 52 (as is describedhereinbelow with reference to FIG. 15D), inner wall 951 pushes onengager 54 such that catheter 14 can be rotated to any suitablerotational orientation within outer catheter 12. For example, engager 54is shown at 2 o'clock in section B-B of FIG. 15B, while engager 54 isshown at 11 o'clock in section B-B of FIG. 15C. Furthermore, prior tothe engaging of engager 54 with slit 52 catheter 14 may be extractedfrom within the lumen of catheter 12.

FIG. 15C shows axial advancement of catheter 14 within catheter 12 inthe distal direction, as indicated by arrow 1, in a manner in whichengager 54 is about to engage with slit 52 at a distal portion ofcatheter 12. FIG. 15C shows a relative position of catheter 14 withrespect to catheter 12 in a manner in which catheter 14 is not fullypushed within catheter 12. Handle 24 of catheter 14 is still distancedfrom handle 22 of catheter 12. However, catheter 14 is pushed distallysufficiently for distal end 104 and a portion of the distal end portionof catheter 14 to emerge from within catheter 12 and extend distallybeyond distal end 102 of catheter 12.

Following further distal advancement of catheter 14 within catheter 12,and slight rotation of catheter 14 within the lumen of catheter 12,engager 54 of catheter 14 is aligned with slit 52 of catheter 12, asshown in FIG. 15D. In the absence of the pushing force of inner wall 951of catheter 12 on engager 54, engager 54 returns to its resting stateand protrudes within slit 52 so as to engage slit 52. That is, firstcoupling 152 is engaged with second coupling 154. As engager 54 returnsto its resting state, tab 56 returns to a position in which it isparallel with respect to longitudinal axis 7.

FIG. 15D shows engager 54 in a distal-most position within slit 52,i.e., a fully-pushed state of catheter 14. As such, handles 24 and 22are disposed adjacently to each other. In this state, an exposed distalend portion 114 of catheter 14 extends beyond distal end 102 of catheter12. Typically, at least a portion of distal end portion 114 is steerableand bendable, as is described hereinbelow. Distal end portion 114 ofcatheter 14 has a length L3 of between 25 and 35 mm, e.g., 30 mm. Asdescribed hereinabove, slit 52 has a length L2 of between 5 and 15 mm,e.g., 10 mm.

Reference is now made to FIGS. 13 and 3D. As shown in view B of FIG. 13,engager 54 has a longitudinal length L26 of between 2 and 3 mm, e.g., 2mm. Length L26 facilitates motion of engager 54 along length L2 of slit52. A proximal-most end of engager 54 is disposed up to 120 mm (e.g., upto 80 mm) from distal end 104 of catheter 14. As described hereinabove,a proximal-most end of slit 52 is disposed up to 100 mm (e.g., up to 60mm) from distal end 102 of catheter 12. Thus, since slit 52 has a lengthL2 of between 5 and 15 mm, e.g., 10 mm, when engager 54 is disposed at adistal-most position within slit 52, as shown in FIG. 15D, exposeddistal end portion 114 of catheter 14 has a length L3 of between 20 and35 mm, e.g., 30 mm.

For some applications, the combined lengths of first and secondcouplings 152 and 154, respectively, is less than 30 mm, e.g., less than20 mm. For applications in which first coupling 152 (e.g., slit 52) isbetween 5 and 15 mm, and second coupling 154 (e.g., engager 54) isbetween 2 and 3 mm, the combined lengths of first and second couplings152 and 154, respectively, is less than 50 mm, e.g., less than 20 mm.

Engager 54 has a longitudinal length L26 that is less than 30% (e.g.,less than 20%) of the longitudinal length of catheter 14. Typically,however, as described hereinabove, engager 54 has a length L26 ofbetween 2 and 3 mm. That is, engager 54 has a longitudinal length thatis less than 2% (e.g., less than 1%) of the longitudinal length ofcatheter 14.

Reference is now made to FIGS. 15C-D. A portion of exposed distal endportion 114 extends beyond distal end 102 of catheter 12 prior toengager 54 engaging slit 52. The length L2 of slit 52 enables retractionof catheter 14 between 5 and 15 mm, proximally from the fully-pushedstate of catheter 14. As catheter 14 is retracted proximally, engager 54moves proximally within slit 52 until a proximal-most end of engager 54contacts a proximal-most end of slit 52. When engager 54 is disposed atthe proximal-most end of slit 52, the distal end portion exposed fromwithin catheter 12 is between 10 and 30 mm, e.g., 20 mm. When catheter14 is pushed distally, engager 54 moves distally within slit 52 until adistal-most end of engager 54 contacts a distal-most end of slit 52.

Reference is again made to FIG. 15D. In the state in which engager 54 isdisposed within slit 52, catheter 14 is restricted from rotating withinthe lumen of catheter 12, and catheters 12 and 14 are therebyrotationally locked with respect to each other.

FIG. 15E shows catheter 12 and 14 in a state in which catheter 14 hasbeen pushed fully within catheter 12 (i.e., a state in which engager 54is disposed at a distal-most end of slit 52 and handle 24 is disposedadjacently to handle 22). As described hereinabove, during thefully-pushed state of catheter 14, exposed distal end portion 114extends beyond distal end 102 of catheter 12 and has a length L3 ofbetween 25 and 35 mm, e.g., 30 mm. Additionally, as is described herein,at least a portion of distal end portion 114 is steerable and comprisesan exposed bending section 1403 which is a portion of a collectivedistal bending section 1405 of catheter 14 (described hereinbelow withreference to FIGS. 17 and 18). A distal end portion of catheter 12comprises a bending section 1203 (described hereinbelow with referenceto FIGS. 16 and 18). A proximal portion of bending section 1405 ofcatheter 14 is bendable and disposed within the lumen of catheter 12 atbending section 1203 thereof.

The distal end portion of catheter 12 is steerable in a first plane(e.g., a plane that is parallel with respect to the cardiac valve of thepatient). Bending section 1403 of exposed distal end portion 114 (andadditional portions of collective bending section 1405) is steerable insecond plane that is substantially perpendicular to the first plane inwhich the distal end portion of catheter 12 is steerable (e.g., a planethat is perpendicular with respect to the valve of the patient). Asshown, bending section 1203 of the steerable distal end portion of outercatheter 12 is maintained in its steered configuration, or in itsspatial orientation, without substantially affecting the steering ofexposed distal end portion 114 of guide catheter 14, nor of the bendingof bending section 1403, nor of the collective bending section 1405(including the proximal portion of bending section 1405 of catheter 14that is disposed within the lumen of catheter 12 at bending section 1203thereof). That is, first and second couplings 152 and 154, respectively,advantageously reduce the effect of the distal end portion of catheter12 on the steering of distal end portion 114 and the bending of bendingsection 1405. That is, first and second couplings 152 and 154 of outercatheter 12 and guide catheter 14, respectively, collectively define arelative-spatial-orientation-controlling device which rotationally locksthe relative spatial orientation of the steerable distal end portion andbending section 1203 of outer catheter 12 with respect to the steerabledistal end portion and bending section 1405 of guide catheter 14,specifically of exposed bending section 1403.

Thus, for applications in which system 10 is used to treat the mitralvalve, bending section 1203 of catheter 12 bends the steerable distalend portion of catheter 12 within the atrium in the first plane that isparallel with respect to the mitral valve. First and second couplings152 and 154, respectively, enable (1) bending of bending section 1405toward the valve in the second plane that is substantially perpendicularwith respect to the first plane and to the plane of the mitral valve,while (2) restricting or minimizing the effect of the spatialorientation of bending section 1203 of catheter 12 on bending section1405 of catheter 14.

Reference is now made to FIGS. 15A-E. It is to be noted that for someapplications, slit 52 has a longitudinal length L2 of less than 20 cm,e.g., a length of less than 15 cm. That is, slit 52 has a longitudinallength L2 that is less than 30% (e.g., less than 20%) of thelongitudinal length of catheter 12. Typically, however, as describedhereinabove, slit 52 has a length L2 of between 5 and 15 mm, e.g., 10mm. That is, slit 52 has a longitudinal length that is less than 2%(e.g., less than 1%) of the longitudinal length of catheter 12. For suchapplications, the proximal-most end of slit 52 is disposed up to 30 mmfrom distal end 102 of catheter 12.

It is to be noted that the scope of the present invention includesproviding slit 52 and engager 54 at respective proximal portions ofcatheters 12 and 14, respectively. For such applications, a distal-mostend of slit 52 is disposed up to 100 mm (e.g., up to 60 mm) from theproximal end of catheter 12 and a distal-most end of engager 54 isdisposed up to 120 mm (e.g., up to 80 mm) from the proximal end ofcatheter 14.

Reference is now made to FIGS. 13, 14, and 15A-E. It is to be noted thatfirst and second couplings 152 and 154, respectively, may be provided onany standard catheter. That is, coupling 152 comprises frame 50 whichcan be coupled to an external surface of any standard catheter (in whichcase, a corresponding slit would be made in the standard catheter).Additionally coupling 154 may be coupled to any standard catheter bycoupling the base portion of coupling 154 to any standard catheter.Suitable adjustments to the standard catheter would be made toaccommodate the displacing of tab 56 and engager 54 in response topushing forces applied to engager 54.

Reference is now made to FIG. 16, which is a schematic illustration ofcatheter 12 comprising a multiple-durometer section 1210 at a distalsteerable end portion of catheter 12, in accordance with someapplications of the present invention. Multiple-durometer section 1210has a length L18 of between 30 mm and 40 mm, e.g., 36 mm. Each sectionof multiple-durometer section 1210 has a respective durometer sectionsin Shore D, or scale D. Catheter 12 comprises a uniform durometersection 1205 that is disposed proximal to multiple-durometer bendingsection 1210. Typically, multiple durometer section 1210 and uniformdurometer section 1205 comprise an elastic tubular polymer 1206 (e.g.,sequences of polyamide 12 segments (PA12) and polytetramethylene glycolsegments (PTMG), polyether block amide, or PEBA) that defines thetubular structure of catheter 12. Polymer 1206 has mechanical anddynamic properties which impart flexibility, impact resistance, energyreturn, and fatigue resistance to catheter 12.

As shown in the cross-sectional image, catheter 12 provides a wall whichdefines lumen 58. The inner wall of catheter 12 (which defines lumen 58)is coated with a friction-reducing liner comprisingpolytetrafluoroethylene (PTFE) so as to reduce friction during thesliding of catheter 14 through lumen 58 of catheter 12. The wall ofcatheter 12 is shaped so as to define secondary lumens 1211, which aretypically spaced apart from each other by 180 degrees. A respective pullwire 29 a and 29 b (not shown in FIG. 16 for clarity of illustration,but are shown in FIGS. 13 and 14) is advanced through each lumen 1211.The inner walls of each secondary lumen 1211 is coated with afriction-reducing liner comprising polytetrafluoroethylene (PTFE) so asto reduce friction during the sliding of respective wires 29 a and 29 btherethrough.

Typically, catheter 12 has an inner diameter D1 (or the diameter oflumen 58) of between 6.5 and 7.0 mm (e.g., 6.85 mm) and outer diameterD2 of between 8.0 and 9.0 mm (e.g., 8.3 mm).

It is to be noted that even though catheter 12 has multiple durometersegments, inner and outer diameters D1 and D2, respectively, remainconstant along a longitudinal length L8 of catheter 12 (with theexception of outer diameter D2 being tapered at the distal end portionof section 1201, as is described hereinbelow).

Typically, catheter 12 has a longitudinal length L8 of between 800 and900 mm, e.g., between 853 and 867 mm, e.g., 860 mm. Uniform durometersection 1205 has a length L9 that is between 770 and 860 mm, e.g., 824mm. Tubular polymer 1206 extends an entire length L8 of catheter 12.Catheter 12 is surrounded by a braided mesh 1207, which typicallycomprises a flexible metal (e.g., stainless steel 304 or nitinol).Typically, braided mesh 1207 extends along the length of catheter 12until a proximal portion at which the pull wires 29 a and 29 b (notshown for clarity of illustration) are exposed from within lumens 1211at a proximal section of catheter 12, e.g., between 823 and 837 mm(e.g., 830 mm) from distal end 102 of catheter 12.

Section 1210 comprises a distal pull-ring section 1201 in which pullring 11 is disposed. Typically, a distal-most portion of section 1201 istapered so as to facilitate atraumatic advancement of catheter 12through the vasculature of the patient. Section 1201 has a length ofbetween 4 and 5 mm (e.g., 4.5 mm) and has a durometer of between 45D and63D (e.g., 55D). Such a durometer of section 1201 imparts more hardnessand rigidity to the distal portion of catheter 12 in which pull ring 11is disposed, such that section 1201 supports ring 11 and protects thedistal portion of catheter 12 from the impact of forces applied theretoduring the pulling of pull ring 11 by the pull wires. Typically, pullring 11 has a length of between 2.5 and 2.6 mm, e.g., 2.54 mm. A distaltransition section 1202 is disposed proximal to section 1201 and has alength L5 of between 1 and 2 mm (e.g., 1.5 mm) and has a durometer ofbetween 63D and 72D (e.g., 72D). The relatively high durometer ofsection 1202 imparts hardness to section 1202 such that pull ring 11 issupported and maintained in place during the pulling of pull ring 11 bythe pull wires. Thus, section 1202 helps overcome high tensile forcesacting on the distal end of catheter 12.

Catheter 12 provides bending section 1203 proximally adjacent to section1202. As shown in the enlarged image, bending section 1203 comprises acoil 1208 which is embedded within the tubular polymer 1206. Typically,coil 1208 comprises a flexible metal (e.g., stainless steel 304 ornitinol). Coil 1208 imparts efficient and durable bending to bendingsection 1203. Additionally, polymer 1206 at bending section 1203 has adurometer of between 25D and 45D (e.g., 35D) which provides a degree ofsoftness that facilitates bending of the distal steerable portion ofcatheter 12 at bending section 1203. Bending section 1203 has a lengthL6 of between 22 and 27 mm, e.g., 25 mm.

Typically, bending section 1203 has a maximum bending angle between 120and 140 degrees (e.g., 127 degrees). That is, bending section 1203 canbend between 0 and 140 degrees. For some applications, bending section1203 has a pre-shaped angle of between 40 and 55 degrees (e.g., 45degrees) so as to reduce force applied to bending section 1203 ofcatheter 12 by pull wires 29 a and 29 b.

It is to be noted that only tubular polymer 1206 and braided mesh 1207extend proximally and distally beyond bending section 1203.

Proximally adjacent to bending section 1203 is a transition section 1204having a length L7 of between 4 and 6 mm (e.g., 5 mm). Proximallyadjacent to transition section 1203 is uniform durometer section 1205.Uniform durometer section 1205 has a durometer of between 63D and 72D(e.g., 72D). Transition section 1204 has a durometer of between 35D and55D (e.g., 45D) so as to provide a transition from the relatively lowdurometer of bending section 1203 to the relatively high durometer ofuniform durometer section 1205.

FIG. 16 shows the relative position of slit 52 with respect to distalend 102 of catheter 12. As described hereinabove, a proximal-most end ofslit 52 is disposed up to 100 mm (e.g., up to 60 mm) from distal end 102of catheter 12.

Typically, the spatial orientation of bending section 1203 is determinedby pulling on pull wires 29 a and 29 b that are disposed within lumens1211 (wires 29 a and 29 b are not shown for clarity of illustration).Bending section 1203, for some alternative applications of the presentinvention, may be pre-shaped (e.g., at 45 degrees with respect to atransverse plane provided by opposing pull wires 29 a and 29 b) toassume a given spatial orientation and the spatial orientation ofsection 1203 is additionally determined by pulling on pull wires 29 aand 29 b.

Reference is now made to FIG. 17, which is a schematic illustration ofcatheter 14 comprising a multiple-durometer section 1410 at a distalsteerable end portion of catheter 14, in accordance with someapplications of the present invention. Multiple-durometer section 1410has a length L19 of between 70 mm and 80 mm, e.g., 74 mm. Each sectionof multiple-durometer section 1410 has a respective durometer sectionsin Shore D, or scale D. Catheter 14 comprises a uniform durometersection 1407 that is disposed proximal to multiple-durometer bendingsection 1410. Typically, multiple durometer section 1410 and uniformdurometer section 1407 comprise an elastic tubular polymer 1416 (e.g.,sequences of polyamide 12 segments (PA12) and polytetramethylene glycolsegments (PTMG), polyether block amide, or PEBA) that defines thetubular structure of catheter 14. Polymer 1416 has mechanical anddynamic properties which impart flexibility, impact resistance, energyreturn, and fatigue resistance to catheter 14.

As shown in the cross-sectional image, catheter 14 provides a wall whichdefines lumen 59. The inner wall of catheter 14 (which defines lumen 59)is coated with a friction-reducing liner comprisingpolytetrafluoroethylene (PTFE) so as to reduce friction during thesliding of tube 19 (not shown for clarity of illustration, but shown inFIGS. 13 and 14) through lumen 59 of catheter 14. The wall of catheter14 is shaped so as to define secondary lumens 1421, which are typicallyspaced apart from each other by 180 degrees. A respective pull wire 31 aand 31 b (not shown in FIG. 5 for clarity of illustration, but are shownin FIGS. 13 and 14) is advanced through each lumen 1421. The inner wallsof each secondary lumen 1421 is coated with a friction-reducing linercomprising polytetrafluoroethylene (PTFE) so as to reduce frictionduring the sliding of respective wires 31 a and 31 b therethrough.Additionally, the wall of catheter 14 is shaped so as to define asecondary lumen 1422 for passage therethrough of guide member 86 (notshown in FIG. 17 for clarity of illustration, but are shown in FIGS. 13and 14). The inner wall of secondary lumen 1422 is coated with afriction-reducing liner comprising polytetrafluoroethylene (PTFE) so asto reduce friction during the sliding of guide member 86 therethrough.

Typically, catheter 14 has an inner diameter D3 (or the diameter oflumen 59) of between 4.7 and 5.3 mm (e.g., 5.1 mm) and outer diameter D4of between 6.3 and 6.9 mm (e.g., 6.5 mm or 6.7 mm).

It is to be noted that even though catheter 14 has multiple durometersegments, inner and outer diameters D3 and D4, respectively, remainconstant along a longitudinal length L17 of catheter 14.

Typically, catheter 14 has a length L17 of between 1000 and 1500 mm,e.g., between 1190 and 1210 mm, e.g., 1200 mm. Uniform durometer section1407 has a length L16 that is between 900 and 1400 mm, e.g., between1110 and 1130 mm, e.g., 1126 mm. Tubular polymer 1416 extends an entirelength L17 of catheter 14. Catheter 14 is surrounded by a braided mesh1417, which typically comprises a flexible metal (e.g., stainless steel304 or nitinol). Typically, braided mesh 1417 extends along the lengthof catheter 14 until a proximal portion at which the pull wires 31 a and31 b (not shown for clarity of illustration) are exposed from withinlumens 1421 at a proximal section of catheter 14, e.g., between 993 and1007 mm (e.g., 1000 mm) from distal end 104 of catheter 14.

Section 1410 comprises a distal pull-ring section 1401 in which pullring 13 is disposed. Section 1401 has a length of between 3.5 and 4.5 mm(e.g., 4.04 mm) and has a durometer of between 45D and 63D (e.g., 55D).Such a durometer of section 1401 imparts more hardness and rigidity tothe distal portion of catheter 14 in which pull ring 13 is disposed,such that section 1401 supports ring 13 and protects the distal portionof catheter 14 from the impact of forces applied thereto during thepulling of pull ring 13 by the pull wires. Typically, pull ring 13 has alength of between 2.5 and 2.6 mm, e.g., 2.54 mm. A distal transitionsection 1402 is disposed proximal to section 1401 and has a length L11of between 1 and 2 mm (e.g., 1.5 mm) and has a durometer of between 63Dand 72D (e.g., 72D). The relatively high durometer of section 1402imparts hardness to section 1402 such that pull ring 13 is supported andmaintained in place during the pulling of pull ring 13 by the pullwires. Thus, section 1402 helps overcome high tensile forces acting onthe distal end of catheter 14.

Catheter 14 provides collective bending section 1405 proximally adjacentto section 1402. As shown in the enlarged image, bending section 1405comprises a coil 1418 which is embedded within the tubular polymer 1416.Typically, coil 1418 comprises a flexible metal (e.g., stainless steel304 or nitinol). Coil 1418 imparts efficient and durable bending tobending section 1405. Bending section 1405 has a length L14 of between60 and 70 mm, e.g., 62 mm. Collective bending section 1405 comprisesexposed bending section 1403 and a proximal bending section 1404.

Reference is now made to FIG. 18, which is a schematic illustration of arelative spatial orientation of the steerable distal end portions ofcatheters 12 and 14, respectively. Typically, in a fully-pushed state ofcatheter 14 within catheter 12, as described hereinabove, catheter 14provides exposed distal end portion 114 that extends beyond distal end102 of catheter 12. Distal end portion 114 comprises exposed bendingsection 1403. In the fully-pushed state of catheter 14, exposed bendingsection 1403 is configured to be exposed from and extend beyond distalend 102 of catheter 12, while at least a distal portion of proximalbending section 1404 is configured to remain concentrically disposedwithin the lumen of catheter 12 in general alignment with bendingsection 1203 of catheter 12, as indicated by the broken line in FIG. 18.

Reference is now made to FIGS. 17 and 18. Polymer 1416 at exposedbending section 1403 (in FIG. 5) has a durometer of between 20D and 35D(e.g., 25D) which provides a degree of softness at exposed bendingsection 1403 that facilitates bending of section 1403. Additionally,proximal bending section 1404 has a durometer of between 25D and 45D(e.g., 35D) which provides a degree of softness at exposed bendingsection 1404 that facilitates bending of second 1404. It is to be notedthat the durometer of proximal bending section 1404 is higher than thedurometer of exposed bending section 1403. Since the durometer ofproximal bending section 1404 of catheter 14 is generally similar to thedurometer of bending section 1203 of catheter 12, the steering of thedistal end portion of catheter 14 (and of exposed distal end portion114) and the bending of bending section 1405 of catheter 14 (especiallythe bending of exposed bending section 1403) does not substantiallyinfluence the bending and spatial orientation of bending section 1203 atthe distal end portion of catheter 12 when catheter 14 is disposedwithin catheter 12.

Typically, bending section 1405 has a maximum bending angle between 100and 140 degrees (e.g., 117 degrees). That is, bending section 1405 canbend between 0 and 140 degrees. For some applications, at least aportion of bending section 1405 has a pre-shaped angle of between 40 and55 degrees (e.g., 45 degrees) so as to reduce force applied to bendingsection 1405 of catheter 14 by pull wires 31 a and 31 b.

Reference is again made to FIG. 17. It is to be noted that only tubularpolymer 1416 and braided mesh 1417 extend proximally and distally beyondbending section 1405.

Proximally adjacent to bending section 1405 is a transition section 1406having a length L15 of between 4 and 6 mm (e.g., 5 mm). Proximallyadjacent to transition section 1406 is uniform durometer section 1407.Uniform durometer section 1407 has a durometer of between 63D and 72D(e.g., 72D). Transition section 1406 has a durometer of between 35D and55D (e.g., 45D) so as to provide a transition from the relatively lowdurometer of proximal bending section 1404 of bending section 1405 tothe relatively high durometer of uniform durometer section 1407.

FIG. 17 shows the relative position of slit engager 54 with respect todistal end 104 of catheter 14. As described hereinabove, a proximal-mostend of engager 54 is disposed up to 120 mm (e.g., up to 80 mm) fromdistal end 104 of catheter 14.

Typically, the spatial orientation of bending section 1405 is determinedby pulling on pull wires 31 a and 31 b that are disposed within lumens1421 (wires 31 a and 31 b are not shown for clarity of illustration).Bending section 1405, for some alternative applications of the presentinvention, may be pre-shaped to assume a given spatial orientation andthe spatial orientation of section 1405 is additionally determined bypulling on pull wires 31 a and 31 b.

Reference is now made to FIG. 19A, which is a schematic illustration ofa catheter 1012 as described hereinabove with regard to catheter 12 withreference to FIG. 16, with the exception that catheter 1012 comprises atubular portion 1250 that is shaped so as to define slit 52 describedherein, in accordance with some applications of the present invention.Tubular portion 1250 comprises a flexible or rigid metal segment that isshaped to provide first coupling 152. For some applications, slit 52 iscreated in tubular portion 1250. For other applications, frame 50(described hereinabove with reference to FIG. 13) is coupled to tubularportion 1250 in alignment with a slit generated therein.

During manufacture of catheter 1012, tubular portion 1250 is positionedlongitudinally and coaxially between segments of section 1205 ofcatheter 1012. That is, a portion of section 1205 is cut in order togenerate intermediate free ends, and tubular portion 1250 is attached atrespective free ends thereof to the intermediate free ends of section1205. For some applications, catheter 1012 is not cut, but rathercatheter 1012 is comprised of two separate parts, each having free endswhich are each coupled to portion 1250. For some applications, theintermediate free ends are coupled to respective metal segments, andtubular portion 1250 is coupled to the metal segments at theintermediate free ends of catheter 12 by being welded to the metalsegments.

Typically, but not necessarily, the metal of portion 1250 is covered byplastic or the polymer of catheter 12, described hereinabove withreference to FIG. 16.

Typically, the pull wires of catheter 12 described hereinabove withreference to FIG. 14, run through secondary lumens in the wall oftubular portion 1250, or adjacently to the wall of portion 1250.

It is to be noted that tubular portion 1250 may be coupled to anysuitable catheter known in the art.

Reference is now made to FIG. 19B, which is a schematic illustration ofa catheter 1014 as described hereinabove with regard to catheter 14 withreference to FIG. 17, with the exception that catheter 1014 comprises atubular portion 1450 that is shaped so as to define engager 54 and tab56 described herein, in accordance with some applications of the presentinvention. Tubular portion 1450 comprises a flexible or rigid metalsegment that is shaped to provide second coupling 154. That is, tubularportion 1450 provides slits 57 (as shown in FIG. 1) which define tab 56and engager 54. Thus, for some applications, tubular portion 1450 andtab 56 are constructed from a single unit by creating slits in tubularportion 1450, and the protrusion of engager 54 is welded or otherwisecoupled to a distal end of tab 56. For other applications, coupling 154comprises a base which defines tab 56 and provides engager 54, and thebase is coupled to tubular portion 1450.

During manufacture of catheter 1014, tubular portion 1450 is positionedlongitudinally and coaxially between segments of section 1407 ofcatheter 1014. That is, a portion of section 1407 is cut in order togenerate intermediate free ends, and tubular portion 1450 is attached atrespective free ends thereof to the intermediate free ends of section1407. For some applications, catheter 1014 is not cut, but rathercatheter 1014 is comprised of two separate parts, each having free endswhich are each coupled to section 1250. For some applications, theintermediate free ends are coupled to respective metal segments, andtubular portion 1450 is coupled to the metal segments at theintermediate free ends of catheter 14 by being welded to the metalsegments.

Typically, but not necessarily, the metal of portion 1450 is covered byplastic or the polymer of catheter 14, described hereinabove withreference to FIG. 17.

Typically, the pull wires of catheter 14 described hereinabove withreference to FIG. 14, run through secondary lumens in the wall oftubular portion 1450, or adjacently to the wall of portion 1450.

It is to be noted that tubular portion 1450 may be coupled to anysuitable catheter known in the art.

Reference is now made to FIGS. 20A-I, which are schematic illustrationsof a procedure for implanting an annuloplasty ring structure 222 torepair a mitral valve 230, in accordance with an application of thepresent invention. This procedure is one exemplary procedure that can beperformed using system 10.

Annuloplasty ring structure 222 is used to repair a dilated valveannulus of an atrioventricular valve, such as mitral valve 230. For someapplications, the annuloplasty ring is configured to be placed onlypartially around the valve annulus (e.g., to assume a C-shape), and,once anchored in place, to be contracted so as to circumferentiallytighten the valve annulus. The annuloplasty ring comprises flexiblesleeve 26 and a plurality of anchors 32. Anchor deployment manipulator61 is advanced into a lumen of sleeve 26, and, from within the lumen,deploys the anchors through a wall of the sleeve and into cardiactissue, thereby anchoring the sleeve around a portion of the valveannulus. For some application, annuloplasty ring structure 222 isimplemented using techniques described in U.S. application Ser. No.12/437,103, filed May 7, 2009 which published as US 2010/0286767, and/orU.S. application Ser. No. 12/689,635, filed Jan. 19, 2010 whichpublished as US 2010/0280604, both of which are assigned to the assigneeof the present application and are incorporated herein by reference. Asdescribed hereinabove, annuloplasty ring structure 222 comprisesadjustment mechanism 40. The adjustment mechanism comprises a rotatablestructure, such as a spool, arranged such that rotation of the rotatablestructure contracts the implant structure. The implant further comprisesa longitudinal member, such as a wire, which is coupled to theadjustment mechanism. A rotation tool is provided for rotating therotatable structure. The tool is configured to be guided along (e.g.,over, alongside, or through) the longitudinal member, to engage therotatable structure, and to rotate the rotatable structure in responseto a rotational force applied to the tool.

As shown in FIG. 20A, the procedure typically begins by advancing asemi-rigid guidewire 202 into a right atrium 220 of the patient. Theprocedure is typically performed with the aid of imaging, such asfluoroscopy, transesophageal echo, and/or echocardiography.

As show in FIG. 20B, guidewire 202 provides a guide for the subsequentadvancement of outer catheter 12 therealong and into the right atrium.Once a distal portion of catheter 12 has entered the right atrium,guidewire 202 is retracted from the patient's body. Catheter 12typically comprises a 14-24 F sheath, although the size may be selectedas appropriate for a given patient. Catheter 12 is advanced throughvasculature into the right atrium using a suitable point of origintypically determined for a given patient. For example:

-   -   catheter 12 may be introduced into the femoral vein of the        patient, through an inferior vena cava 223, into right atrium        220, and into a left atrium 224 transseptally, typically through        the fossa ovalis;    -   catheter 12 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into right atrium        220, and into left atrium 224 transseptally, typically through        the fossa ovalis; or    -   catheter 12 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into        right atrium 220, and into left atrium 224 transseptally,        typically through the fossa ovalis.

For some applications of the present invention, catheter 12 is advancedthrough inferior vena cava 223 of the patient (as shown) and into rightatrium 220 using a suitable point of origin typically determined for agiven patient.

Catheter 12 is advanced distally until the sheath reaches theinteratrial septum, and guidewire 202 is withdrawn, as shown in FIG.20C.

As shown in FIG. 20D, a resilient needle 206 and a dilator (not shown)are advanced through catheter 12 and into the heart. In order to advancecatheter 12 trans septally into left atrium 224, the dilator is advancedto the septum, and needle 206 is pushed from within the dilator and isallowed to puncture the septum to create an opening that facilitatespassage of the dilator and subsequently catheter 12 therethrough andinto left atrium 224. The dilator is passed through the hole in theseptum created by the needle. Typically, the dilator is shaped to definea hollow shaft for passage along needle 206, and the hollow shaft isshaped to define a tapered distal end. This tapered distal end is firstadvanced through the hole created by needle 206. The hole is enlargedwhen the gradually increasing diameter of the distal end of the dilatoris pushed through the hole in the septum. As shown in FIG. 16, forexample, a distal-most end 102 of catheter 12 is tapered so as tofacilitate passage of the distal portion of catheter 12 through theopening in the septum.

The advancement of catheter 12 through the septum and into the leftatrium is followed by the extraction of the dilator and needle 206 fromwithin catheter 12, as shown in FIG. 20E. Once the distal portion ofcatheter 12 is disposed within atrium 224, the steerable distal endportion of catheter 12 (which includes at least a portion of bendingsection 1203, as described hereinabove with reference to FIGS. 16 and18) is steered in a first plane that is parallel to a plane of theannulus of mitral valve 230. Such steering moves the distal end portionof catheter 12 in a direction from the interatrial septum towardsurrounding walls of the atrium, as indicated by the arrow in atrium224. As described hereinabove, steering of the distal portion ofcatheter 12 is performed via steering knob 210 of handle 22 in handleportion 101 (in FIGS. 13 and 14).

As shown in FIG. 20F, annuloplasty ring structure 222 (not shown forclarity of illustration, with anchor deployment manipulator 61 therein)is advanced through guide catheter 14, which is in turn, advancedthrough catheter 12 into left atrium 224. As shown in FIG. 20F, exposeddistal end portion 114 of catheter 14 extends beyond distal end 102 ofcatheter 12. Exposed distal end portion 114 is then (1) steered towardthe annulus of valve 230 along a plane that is perpendicular withrespect to the steering plane of catheter 12 and that is perpendicularwith respect to valve 230, and is (2) bent, via bending section 1403 (asdescribed hereinabove with reference to FIGS. 17 and 18) toward valve230. As described hereinabove, steering of the distal portion ofcatheter 14 is performed via steering knob 214 of handle 24 in handleportion 101 (in FIGS. 13 and 14).

As shown in FIG. 20G, a distal end 251 of sleeve 26 is positioned in avicinity of a left fibrous trigone 242 of an annulus 240 of mitral valve230. (It is noted that for clarity of illustration, distal end 251 ofsleeve 26 is shown schematically in the cross-sectional view of theheart, although left trigone 242 is in reality not located in the showncross-sectional plane, but rather out of the page closer to the viewer.)Alternatively, the distal end of sleeve 26 is positioned in a vicinityof a right fibrous trigone 244 of the mitral valve (configuration notshown). Further alternatively, the distal end of the sleeve is notpositioned in the vicinity of either of the trigones, but is insteadpositioned elsewhere in a vicinity of the mitral valve, such as in avicinity of the anterior or posterior commissure. Once positioned at thedesired site near the selected trigone, deployment manipulator 61deploys a first anchor 32 through the wall of sleeve 26 (by penetratingthe wall of the sleeve in a direction in a direction parallel to acentral longitudinal of deployment manipulator 61, or anchor driver 36,through the distal end of channel 18, and/or parallel to centrallongitudinal axis of tissue coupling element 60 of anchor 32) intocardiac tissue near the trigone. Following the deployment of anchor 32in the cardiac tissue, deployment element 38 is decoupled from anchor 32by moving rod 130 proximally.

Anchors 32 are typically deployed from a distal end of manipulator 61while the distal end is positioned such that a central longitudinal axisthrough the distal end of manipulator 61 forms an angle with a surfaceof the cardiac tissue of between about 20 and 90 degrees, e.g., between45 and 90 degrees, such as between about 75 and 90 degrees, such asabout 90 degrees. Typically, anchors 32 are deployed from the distal endof manipulator 61 into the cardiac tissue in a direction parallel to thecentral longitudinal axis through the distal end of manipulator 61. Suchan angle is typically provided and/or maintained by channel 18 beingmore rigid than sleeve 26. Distal end 17 (shown in FIG. 2) of channel 18is typically brought close to the surface of the cardiac tissue (and thewall of sleeve 26 that is disposed against the surface of the cardiactissue), such that little of each anchor 32 is exposed from channel 18before penetrating the sleeve and the tissue. For example, distal end 17of channel 18 may be placed (e.g., pushed) against the wall of thesleeve, sandwiching the sleeve against the cardiac tissue.

Reference is now made to FIGS. 14 and 20G. As shown on the right side ofFIG. 14, channel 18 is a tube which has an opening 1118 at distal end 17of channel 18. As shown in 20G, during the sandwiching, channel 18sandwiches a portion of the wall of the sleeve between the opening (notshown in FIG. 20G for clarity of illustration) in channel 18 and aregion of cardiac tissue. During the sandwiching, anchor 32 is deployed.

For some applications, this placement of distal end 17 of channel 18against the cardiac tissue (via the wall of the sleeve), stabilizes thedistal end during deployment and anchoring of each anchor 32, andthereby facilitates anchoring. For some applications, pushing of distalend 17 against the cardiac tissue (via the wall of the sleeve)temporarily deforms the cardiac tissue at the site of contact. Thisdeformation may facilitate identification of the site of contact usingimaging techniques (e.g., by identifying a deformation in the borderbetween cardiac tissue and blood), and thereby may facilitate correctpositioning of the anchor.

For some applications of the present invention, anchors 32 may bedeployed from a lateral portion of manipulator 61.

Reference is now made to FIGS. 20G and 1B. It is to be noted thatmechanism 40 shown in FIG. 1B is coupled to sleeve 26 using connectors27.

Reference is now made to FIGS. 20G and 14. Following the deployment ofthe first anchor, a distal portion of sleeve 26 is decoupled from aportion of implant-decoupling channel 18. In order to decouple theportion of sleeve 26 from outer surface of channel 18, (1) channel 18 ispulled proximally, while (2) reference-force tube 19 is maintained inplace in a manner in which a distal end of tube 19 provides a referenceforce to sleeve 26 in order to facilitate retraction freeing of asuccessive portion of sleeve 26 from around channel 18. In order todecouple sleeve 26 from the outer surface of channel 18, (1) channel 18is pulled proximally, while (2) reference-force tube 19 is maintained inplace. An indicator 2120 (shown herein with reference to FIGS. 30A-B) onhandle 126 provides an indication of how much channel 18 is withdrawnfrom within sleeve 26 (i.e., how much the delivery tool is decoupledfrom sleeve 26, and how much the sleeve has advanced off channel 18 andagainst tissue). A proximal end of channel 18 is coupled to a knob 94(FIG. 14) which adjusts an axial position of channel 18 proximally anddistally with respect to reference-force tube 19 and sleeve 26. As shownin FIG. 20H, deployment manipulator 61 is repositioned along annulus 240to another site selected for deployment of a second anchor 32. Referenceis now made to FIGS. 13 and 20H. Such repositioning of manipulator 61 isaccomplished by:

1. the steering of the distal end portion of catheter 12 (e.g., bysteering knob 210 of handle 22) in the first plane that is parallel withrespect to annulus 240 of valve 230 to a desired spatial orientation andin a manner which bends bending section 1203 of catheter 12,

2. the steering of the distal end portion of portion of catheter 14(e.g., by steering knob 214 of handle 24) in the second plane that isperpendicular with respect to annulus 240 of valve 230 to a desiredspatial orientation, and in a manner which bends bending section 1405 ofcatheter 14 (specifically bending section 1403),

3. by axially moving catheter 14 with respect to catheter 12 via knob216,

4. by axially moving the stand supporting handles 22 and 24 to move bothcatheters 12 and 14,

5. by moving tube 19 and sleeve 26 axially by sliding mount 93 alongtrack 90 via knob 95, and/or

6. by moving channel 18 relative to tube 19 by actuating knob 94.

Typically, the first anchor is deployed most distally in the sleeve(generally at or within a few millimeters of the distal tip of thesleeve), and each subsequent anchor is deployed more proximally, suchthat the sleeve is gradually decoupled from channel 18 of deploymentmanipulator 61 in a distal direction during the anchoring procedure(i.e., channel 18 is withdrawn from within sleeve 26, and handle 126 ismoved distally so as to retract the tool to make the successive proximalportion sleeve 26 ready for implantation of a subsequent anchor). Thealready-deployed first anchor 32 holds the anchored end of sleeve 26 inplace, so that the sleeve is drawn from the site of the first anchortowards the site of the second anchor. Typically, as sleeve 26 isdecoupled from channel 18, deployment manipulator 61 is moved generallylaterally along the cardiac tissue, as shown in FIG. 20H. Deploymentmanipulator 61 deploys the second anchor through the wall of sleeve 26into cardiac tissue at the second site. Depending on the tension appliedbetween the first and second anchor sites, the portion of sleeve 26therebetween may remain tubular in shape, or may become flattened, whichmay help reduce any interference of the ring with blood flow.

As shown in the enlarged in-phantom image to the right, duringrepositioning of manipulator 61, a generally-triangular shape is formedbetween: (1) guide member 86, (2) a distal portion of sleeve 26, and (3)channel 18 surrounded partially by catheter 14. It is to be noted thatthe illustrated triangle is shown in phantom to indicate the relativetriangular orientation of the three components, and that the illustratedtriangle is not a part of the apparatus shown.

As shown in FIG. 20I, deployment manipulator 61 is repositioned alongthe annulus to additional sites, at which respective anchors aredeployed, until the last anchor is deployed in a vicinity of rightfibrous trigone 244 (or left fibrous trigone 242 if the anchoring beganat the right trigone). Alternatively, the last anchor is not deployed inthe vicinity of a trigone, but is instead deployed elsewhere in avicinity of the mitral valve, such as in a vicinity of the anterior orposterior commissure. Then, system 10 is removed, leaving behind guidemember 86. A rotation tool is then threaded over and advanced alongguide member 86 toward adjustment mechanism 40, and is used to rotatethe spool of adjustment mechanism 40 in order to tighten structure 222by adjusting a degree of tension of contracting member 226 (not shown inFIG. 20I, but shown in FIG. 5B). Once the desired level of adjustment ofstructure 222 is achieved (e.g., by monitoring the extent ofregurgitation of the valve under echocardiographic and/or fluoroscopicguidance), the rotation tool and guide member 86 are removed from theheart. For some applications, a distal portion of guide member 86 may beleft within the heart of the patient and the proximal end may beaccessible outside the body, e.g., using a port. For such applications,adjustment mechanism 40 may be accessed at a later stage followinginitial implantation and adjustment of ring structure 222.

As shown, sleeve 26 of ring structure 222 comprises a plurality ofradiopaque markers 25, which are positioned along the sleeve atrespective longitudinal sites to indicate anchor-designated targetareas. The markers may provide an indication in a radiographic image(such as a fluoroscopy image) of how much of sleeve 26 has been deployedat any given point during an implantation procedure, in order to enablesetting a desired distance between anchors 32 along the sleeve 26.

Alternatively, annuloplasty ring structure 222 is implanted by right orleft thoracotomy, mutatis mutandis.

As shown, mechanism 40 is coupled typically coupled to sleeve 26 via oneor more connectors 27, such as sutures, which provide flexible and/orarticulated coupling. A proximal end of connector 27 is disposedproximally to mechanism 40 (e.g., by being fixed to a portion of sleeve26 proximal to mechanism 40 or by being accessible outside the body ofthe patient). A distal end of connector 27 is coupled (e.g., by beingfixedly coupled by a knot or other mechanical coupling) to mechanism 40.Guide member 86, described hereinabove, typically extends distally fromcatheter 14, between end 251 of sleeve 26 and adjustment mechanism 40,and there is coupled to the adjustment mechanism. For some applicationsit is advantageous to (1) advance the structure to the mitral valvewhile mechanism 40 is disposed on the longitudinal axis of sleeve 26(e.g., collinearly with the sleeve), so as to maintain a smallcross-sectional diameter of the structure for transluminal delivery; and(2) to subsequently move mechanism 40 away from the longitudinal axis,e.g., so as to allow the distal end wall of sleeve 26 to be placedagainst the annulus, and/or so as to allow an anchor to be driventhrough the end wall of the sleeve. Connectors 27 facilitate thistechnique by making mechanism 40 flexibly and/or articulatably coupledto sleeve 26. For some applications, connectors 27 are tensioned orrelaxed to move mechanism 40 with respect to sleeve 26 to repositionmechanism 40. For some applications, guide member 86 is tensioned orrelaxed in order to reposition mechanism 40. For some applications,connectors 27 comprise a hinge.

For some applications of the present invention, following implantationof sleeve 26 along the annulus, an excess portion of sleeve 26 may bepresent at the proximal portion of sleeve. In such applications,following removal of manipulator 61, a cutting tool (not shown) may beadvanced within channel 18 and into the lumen of the excess portions ofsleeve 26 (e.g., from within sleeve 26) in order to cut the sleeveproximal to the proximal-most-deployed anchor 32.

Reference is now made to FIGS. 6A-I and 20A-I. It is to be noted thattechniques for implantation of structure 222 shown in FIGS. 20A-I may beemployed in techniques for implantation of ring 3022, as describedherein with respect to FIGS. 6A-I. For example, ring 3022 may compriseguide member 86, as shown in FIGS. 20G-I.

Reference is made to FIG. 21. For some applications of the presentinvention, annuloplasty ring structure 222 is used to treat anatrioventricular valve other than the mitral valve, i.e., tricuspidvalve 231, using system 10 in a similar method as described hereinabovewith reference to FIGS. 20A-I, in accordance with some applications ofthe present invention.

For these applications, ring structure 222 and other components ofsystem 10 described hereinabove as being placed in the left atrium areinstead placed in the right atrium 220. FIG. 21 shows accessing rightatrium 220 through superior vena cava 225 by way of illustration and notlimitation. Components of system 10 may be advanced into the rightatrium through inferior vena cava 223.

Reference is now made to FIGS. 22A-D, which are schematic illustrationsof an indicator and locking system 1700 comprising (1) a protrusion 1724coupled to guide-catheter handle 24, and (2) a housing 1702, or cradle,shaped to define a groove 1704 configured to receive protrusion 1724, inaccordance with some applications of the present invention. System 1700is configured to provide an indication, at a proximal location outsidethe body of the patient, of the state of coupling of first and secondcouplings 152 and 154 of outer catheter 12 and guide catheter 14,respectively (i.e., when engager 54 is received within slit 52 at thedistal end portions of catheters 14 and 12, respectively). Additionally,system 1700 is configured to rotationally lock catheter 12 to catheter14, as is described hereinbelow.

Housing 1702 comprises a handle portion that is coupled to a proximalend of catheter 12. As shown, groove 1704 is shaped so as to define acurved groove along a lateral portion of housing 1702. Groove 1704extends between 45 and 135 rotational degrees, e.g., 90 degrees, asshown.

As described hereinabove with reference to FIGS. 13-14, proximal handleportion 101 is supported by a stand having support legs 91 (i.e., firstleg 91 a and second leg 91 b, as shown in FIGS. 22A-D). As shown inFIGS. 22A-D, first leg 91 a (which is configured to receiveguide-catheter handle 24) provides housing 1702. As describedhereinabove, guide catheter 14 is first advanced within the lumen ofouter catheter 12 when the physician places the distal end of catheter14 within the lumen of catheter 12 (via outer-catheter handle 22) andadvances handle 24 (coupled to the proximal end of catheter 14) towardhandle 22, as indicated by the arrow in FIG. 22A. As describedhereinabove with reference to FIGS. 15A-B, since the lumen of catheter12 is free from any protrusions or recessed portions, and since engager54 is depressible by tab 56, catheter 14 is configured to enter thelumen of catheter 12 in any rotational configuration thereof. As handle24 is advanced toward handle 22, protrusion 1724 of handle 24 advancestoward groove 1704. Groove 1704 is shaped to provide a protrusion-accesslocation 1706 and a protrusion-locking location 1708, which locationsare typically but not necessarily spaced 90 degrees apart.Protrusion-locking location 1708 is shaped to provide a depressiblelocking element 1710 which comprises a depressible pin to lockprotrusion 1724 in place, as is described hereinbelow.

As shown in FIG. 22B, when handle 24 has been pushed distally towardhandle 22, protrusion 1724 advances toward groove 1704 in order toengage protrusion-access location 1706 thereof. Depending on therotational orientation of handle 24 with respect to handle 22, thephysician may need to rotate handle 24 to bring protrusion 1724 inalignment with protrusion-access location 1706 of groove 1704. Onceprotrusion 1724 is in alignment with protrusion-access location 1706,handle 24 is further pushed distally in order to engage protrusion 1724with protrusion-access location 1706 of groove 1704. Once protrusion1724 is located within protrusion-access location 1706 of groove 1704,engager 54 is disposed in proximity with (e.g., in a distal location inthe vicinity of) slit 52. As shown in the enlarged image at the distalend portion of system 10 and in section A-A, when protrusion 1724 islocated within protrusion-access location 1706 of groove 1704, engager54 of catheter 14 is rotationally offset with respect to slit 52 ofcatheter 12 by 90 degrees, by way of illustration and not limitation(i.e., the degrees between protrusion-access location 1706 andprotrusion-locking location 1708).

FIG. 22C shows rotation of catheter 14 with respect to catheter 12, inresponse to rotation of handle 24 in the direction indicated by thearrow. As handle 24 is rotated, protrusion 1724 slides within groove1704 toward protrusion-locking location 1708, as shown in the enlargedimage of a portion of handle 24. As shown in the enlarged section of thedistal end portion of system 10 and in section A-A, as protrusion 1724is being advanced toward protrusion-locking location 1708, engager 54 iscloser to slit 52 and is rotationally offset with respect to slit 52 byfewer degrees than when protrusion 1724 is located at protrusion-accesslocation 1706.

FIG. 22D shows system 1700 following the rotation of handle 24 toposition protrusion 1724 within protrusion-locking location 1708, inorder to rotationally lock catheter 12 to catheter 14 in addition to therotational locking of catheters 12 and 14 provided by insertion ofengager 54 within slit 52, as shown the enlarged section of the distalend portion of system 10 and in section A-A. As protrusion 1724 advancestoward location 1708, protrusion 1724 pushes locking element 1710. Forsome applications, locking element 1710 is spring-loaded, and isconfigured to return to a resting state (as shown in FIG. 22D) in theabsence of force applied thereto. Thus, once protrusion 1724 hasadvanced beyond locking element 1710 into protrusion-locking location1708, element 1710 returns to its resting state to prevent protrusionfrom returning toward protrusion-access location 1706. That is, lockingelement 1710 is only depressible when protrusion 1724 is advanced fromprotrusion-access location 1706 toward protrusion-locking location 1708.In such a manner, groove 1704, protrusion 1724, and locking element 1710of system 1700 rotationally lock catheters 12 and 14 and also preventsaccidental movement of handle 24 with respect to handle 22.

Typically, when protrusion 1724 couples to housing 1702 (e.g., whenprotrusion 1724 locks into protrusion-locking location 1708), coupling154 simultaneously couples to coupling 152.

Reference is now made to FIGS. 13, 15A-E, and 22A-D. For someapplications, two pairs of couplings are thereby provided: (pair 1)couplings 152 and 154 at a distal portion of catheters 12 and 14,respectively, and (pair 2) housing 1702 and protrusion 1724 at aproximal portion of the catheters. It should be noted that, whereascouplings 152 and 154 typically facilitate some longitudinal sliding ofthe distal end of catheter 14 with respect to the distal end of catheter12 (as described hereinabove), housing 1702 and protrusion 1724typically inhibit (e.g., prevent) longitudinal movement of the proximalend of catheter 14 with respect to the proximal end of catheter 12.

Reference is made to FIGS. 23A-C, which are schematic illustrations of atissue anchor 2332 configured for anchoring sleeve 26 describedhereinabove, in accordance with some applications of the presentinvention. Anchor 2332 has a coupling head 2310 configured to be coupledto a deployment element 2338, which has a locking mechanism 2128disposed at a distal end thereof. Typically, deployment element 2338 andlocking mechanism 2128 respectively comprise deployment element 38 andlocking mechanism 128, described hereinabove. For some applications,coupling head 2310 is alternatively or additionally configured to becoupled to, and/or used with, deployment manipulator 61, deploymentelement 38, anchor driver 36, and/or anchor-manipulation tool 1802described hereinabove. Anchor 2332 provides a tissue coupling element2312 (e.g., a helical tissue coupling element, as shown, or a screw).For some applications of the invention, anchor 32 described hereinabove,comprises anchor 2332 and/or anchors 32 and 2332 are interchangeable.

A proximal portion of coupling element 2312 comprises a vertical (andtypically straight) proximal portion 2314 which is coupled to couplinghead 2310 within 3 mm of a central longitudinal axis 2316 of tissueanchor 2332 (e.g., within 1 mm of axis 2316, such as on axis 2316).Proximal portion 2314 may alternatively comprise a proximal stem portionthat couples coupling element 2312 to coupling head 2310. Verticalproximal portion 2314 typically has a length L36 of 0.2-0.7 mm, and istypically more than 1.3 times as great as (e.g., between 2 and 10 timesas great as, such as between 2 and 4 times as great as) a thickness ofthe fabric of sleeve 26. During anchoring of sleeve 26 by anchor 2332(e.g., as shown in FIG. 23B), such a configuration of the positioning ofportion 2314 at the center of coupling head 2310 facilitates rotation oftissue anchor 2332 with respect to sleeve 26 in a manner that preventstwisting of sleeve 26 during rotation. That is, once coupling element2312 has passed far enough through sleeve 26 such that portion 2314traverses the wall of the sleeve (as shown in stage (iii) of FIG. 23B),portion 2314 rotates freely within the wall of the sleeve. (For someapplications in which portion 2314 is coupled to coupling head 2310within 3 mm of, but not on, axis 2316, flexibility of the fabric ofsleeve 26 facilitates such free rotation, by distorting as portion 2314“wiggles”.) Such a configuration allows anchor 2332 to be driven intothe cardiac tissue, such that coupling head 2310 draws sleeve 26 closerto the cardiac tissue, without distorting (e.g., twisting, kinking,buckling, etc.) the sleeve (as shown by the transition from stage (iii)to stage (iv) of FIG. 23B). For some such applications, anchor 2332,coupling element 2312, and/or portion 2314 act as an integral washerand/or a screw with an integral washer, as is known in the hardware art.

Coupling head 2310 may be either male (e.g., a hex or square protrusion)or female (e.g., a straight slot, a hex opening, a Phillips opening, ora Robertson opening). The use of helical anchors, which are screwed intothe cardiac tissue, generally minimizes the force that needs to beapplied during deployment of the anchors into the cardiac tissue. Anchordriver 36 has a deployment element 38 that is either male (e.g.,comprising a screwdriver head, having, such as a slot-head, anAllen-head, a Phillips-head, a Robertson-head, or a hex-head) or female(e.g., comprising a wrench head, having, for example, a square or hexopening), as appropriate for the driving interface provided by couplinghead 2310 of anchor 2332 of FIGS. 23A-C.

Anchor 2332 has an anchor helix diameter L32 of between 0.2 and 0.3 cm,e.g., 0.25 cm. That is, the radius of the anchor helix from longitudinalaxis 2316 is typically between 0.1 and 0.15 cm, e.g., 0.125 cm. Anchor2332 has an anchor helix pitch L33 of between 0.1 and 0.2 cm, e.g., 0.12cm. Anchor 2332 has an anchor helix length L34 of between 0.3 and 0.6cm, such as 0.3 and 0.45 cm, e.g., 0.35 cm. Anchor 2332 has a helix wirethickness L35 of between 0.02 and 0.1 cm, e.g., 0.05 cm.

For some applications of the invention, a torque-limiting apparatus iscoupled to anchor driver 36 and prevents over-rotation of the anchor,penetration of tissue coupling element 2312 too deep into tissue, and/ordamage to the tissue.

For some applications, a ratio between diameter L32 of the helix ofanchor 2332 (cm) to torque (Ncm) is typically, but not necessarily0.25/0.8, or 0.3125. For some applications, a ratio between pitch L33 ofanchor 2332 (cm) to torque (Ncm) is typically, but not necessarily0.12/0.8, or 0.15. For some applications, a ratio between length L34 ofthe helix of anchor 2332 (cm) to torque (Ncm) is typically, but notnecessarily 0.35/0.8, or 0.4375. For some applications, a ratio betweenthickness L35 of the wire forming anchor 2332 (cm) to torque (Ncm) istypically, but not necessarily 0.05/0.8, or 0.0625.

Typically, but not necessarily, anchor 2332 comprises a biocompatiblematerial such as stainless steel 316 LVM. For some applications, anchor2332 comprises nitinol. For some applications, anchor 2332 is coatedwith a non-conductive material.

Reference is now made to FIGS. 1-23B. It is to be noted that any sleeve26 shown in any of the figures shown herein, e.g., FIGS. 1A-B, 3-5B,6G-14, and 20G-21 may be used with any one of the systems describedherein.

Reference is made to FIG. 24, which is a schematic illustration of astate of a distal portion of system 10 within the heart of a subject, inaccordance with some applications of the invention. As generallydescribed hereinabove, (i) catheter 12 is steerable in a first plane,(ii) catheter 14 is steerable in a second plane that is typicallyperpendicular to the first plane, and (iii) distal portions of sleeve 26are laid along the annulus of the native valve while proximal portionsof the sleeve (and the distal end of manipulator 61, within the sleeve)are disposed at a nonzero angle with respect to the annulus. Thus,system 10 is configured to assume a multi-bend formation 2948 (e.g.,handle portion 101 is configured to configure catheter 12, catheter 14,and structure 222 to assume the multi-bend formation) in which at leastthree domains 2950, and at least two bends 2952 separating the domains,are defined.

The formation includes (i) a first bend 2952 a that separates a firstdomain 2950 a of the formation from a second domain 2950 b of theformation, and (ii) a second bend 2952 b that separates the seconddomain from a third domain 2950 c of the formation. Typically, theformation further includes a third bend 2952 c that separates firstdomain 2950 a from a fourth domain 2950 d of the formation. First domain2950 a comprises at least (1) part of catheter 12 and (2) part ofcatheter 14 (i.e., at least a part of catheter 14 disposed withincatheter 12), and typically further comprises at least part of sleeve 26(i.e., at least part of sleeve 26 disposed within catheter 14). Seconddomain 2950 b comprises at least part of catheter 14 (e.g., distal endportion 114 thereof), and at least part of sleeve 26 (e.g., the seconddomain comprises at least part of sleeve 26 disposed within a portion ofcatheter 14 that is exposed from catheter 12). Third domain 2950 ccomprises at least part of sleeve 26, and none of catheters 12 or 14(i.e., the third domain comprises part of sleeve 26 that is disposed outof the distal end of catheter 14). In applications in which formation2948 includes third bend 2952 c and fourth domain 2950 d, the fourthdomain comprises at least (1) part of catheter 12 and (2) part ofcatheter 14 (i.e., at least a part of catheter 14 disposed withincatheter 12), and may further comprise at least part of sleeve 26 (i.e.,at least part of sleeve 26 disposed within catheter 14). Thus, domains2950 a and 2950 d are typically of similar composition, but separated bythird bend 2952 c.

Thus, the proximal extracorporeal handle portion 101 may be consideredto be configured:

to facilitate sliding of the catheter 14 within catheter 12, and slidingof the structure 222 within catheter 14, to drive at least (i) part ofcatheter 12 and (ii) part of catheter 14 to define first domain 2950 a,to drive at least part of catheter 14 that is disposed outside ofcatheter 12 to define second domain 2950 b, to drive system 10 to definethird domain 2950 c from sleeve 26, and typically, to drive at least (i)part of catheter 12 and (ii) part of catheter 14 to define fourth domain2950 d.

As shown, during anchoring of sleeve 26 (e.g., typically duringanchoring of a second anchor 32 bb), a generally-triangular shape isformed between: (1) guide member 86, (2) a distal portion of sleeve 26,and (3) channel 18 surrounded partially by catheter 14. It is to benoted that the illustrated triangle is shown in phantom to indicate therelative triangular orientation of the three components, and that theillustrated triangle is not a part of the apparatus shown. For example,a generally-triangular shape is formed in the apparatus between: (1) theguide member, (2) the distal portion of the implant structure at atleast a portion of the third domain, and (3) at least a portion of thesecond domain.

Reference is now made to FIGS. 6A-I, 20A-I, and 24. It is to be notedthat techniques for implantation of structure 222 for creating themulti-bend structure shown in FIG. 24 may be employed in techniquesdescribed for implantation of ring 3022 in FIGS. 6A-I and in techniquesdescribed for implantation of structure 222 in FIGS. 20A-I. For example,the multi-bend formation 2948 is shown in FIG. 6H.

Reference is now made to FIGS. 6H and 24. When system 10 formsmulti-bend formation 2948, a first-deployed tissue anchor 32 aa anchorsa distal end portion of the longitudinal implant (i.e., ring 3022 inFIG. 6H and structure 222 in FIG. 24) to tissue of the subject. Tissueanchor 32 aa facilitates the formation of second bend 2952 b before andduring placement of a second-deployed anchor 32 bb by applying areference force to the implant at the distal end portion of the implant.Additionally, the tube that is disposed within the sleeve 26 (i.e.,manipulator 61 in FIG. 6H and channel 18 in FIG. 24) facilitates theformation of second bend 2952 b before and during placement of asecond-deployed anchor 32 bb by applying a reference force to theimplant along the second domain 2950 b.

Reference is made to FIGS. 6A-I and 24. It is to be noted thatannuloplasty ring 3022 of FIGS. 6A-I can be used in the procedure asdescribed in FIG. 24, and structure 222 of FIG. 24 can be used in theprocedure as described in FIGS. 6A-I. Additionally, manipulator 61 ofFIGS. 6A-I can be used in the procedure as described in FIG. 24, andchannel 18 of FIG. 24 can be used in the procedure as described in FIGS.6A-I. Reference is now made to FIGS. 15A-E, 22A-D, and 24. FIGS. 15A-Edescribe a first locking mechanism of system 10. The first lockingmechanism is located at respective distal portions of outer catheter 12and guide catheter 14. The first locking mechanism is configured torotationally lock catheter 12 with respect to catheter 14 at theirrespective distal portions. For example, and as shown, the first lockingmechanism comprises (1) first coupling 152 (e.g., slit 52) at the distalportion of outer catheter 12, and (2) second coupling 154 (e.g.,depressible engager 54 comprising a detent) at the distal portion ofguide catheter 14. FIGS. 22A-D describe a second locking mechanism ofsystem 10 and how it functions together with the first locking mechanismat the distal end of catheters 12 and 14. The second locking mechanismis located at the proximal extracorporeal handle portion 101 atrespective proximal portions of outer catheter 12 and guide catheter 14.The second locking mechanism is configured to rotationally lock catheter12 with respect to catheter 14 at their respective proximal portions andat the proximal extracorporeal handle portion 101. For example, and asshown, the second locking mechanism comprises (1) housing 1702 shaped todefine a groove 1704, and (2) protrusion 1724 at a proximal portion ofcatheter 14 for engaging groove 1704 of housing 1702 of the secondlocking mechanism to lock the guide catheter 14 to outer catheter 12.For some applications, the first and the second locking mechanisms areconfigured to lock substantially simultaneously.

The first and second locking mechanisms enable steering of the distalportion of the catheter 14 in any one or more suitable planes withrespect to the distal portion of catheter 12 in a manner whichsubstantially maintains the spatial, angular, and rotational orientationof catheter 12 during the steering of catheter 14. In such a manner, forexample, the first and second locking mechanisms enable catheters 12 and14 to assume multi-bend formation 2948 shown in FIG. 24. With such arotational locking provided by the first and/or second lockingmechanism, during steering of catheter 14, catheter 14 will not tend toassume the rotational configuration and angular, curved orientation ofcatheter 12, and vice versa. Additionally, catheter 12 may be furthersteered without substantially disrupting the spatial, angular, androtational orientation of the distal portion of catheter 14, and viceversa.

Reference is now made to FIG. 25, which is a schematic illustration of akit 4000 comprising components of multi-component tubular system 10, inaccordance with some applications of the present invention. As shown,kit 4000 comprises the components shown hereinabove with reference toFIGS. 13 and 14. That is, kit comprises catheter 12 coupled to handle22, catheter 14 coupled to handle 24, handle 126 coupled toreference-force tube 19 (housing channel 18, not shown), annuloplastyring structure 222 comprising sleeve 26 and mechanism 40, anchor driver36 coupled to housing 135, and a plurality of tissue anchors 32. It isto be noted that although FIG. 25 shows a portion of the referencenumbers shown in FIGS. 13 and 14, kit 4000 comprises all of thecomponents described hereinabove with reference to FIGS. 13-19B and22A-23C.

As shown, kit 4000 comprises a single anchor driver 36. It is to benoted that for some applications, a single driver 36 is configured toanchor all of anchors 32 by being reloaded with each anchor subsequentlyto deploying the previous anchor 32. That is, anchor driver 36 isremoved from the body subsequently to deploying each anchor 32. Forother applications, driver 36 comprises an anchor storage unit. That is,anchor driver 36 is not removed from the body subsequently to deployingeach anchor 32, only after the last anchor is deployed. Alternatively,for some applications, kit 4000 comprises a plurality of anchor drivers36 coupled to a plurality of anchors 32, respectively.

Kit 4000 comprises a kit for repairing a cardiac valve. As describedhereinabove, catheter 14 sized for delivery through vasculature of asubject (i.e., typically through catheter 12). Catheter 14 defines adelivery passage (e.g., its lumen) and has an elongated catheter axisextending therethrough. Structure 222 an elongated and flexibleannuloplasty structure which comprises sleeve 26 having an elongatedlumen therein. Structure 222 has a structure axis extending along thelumen. Structure 222 is sized and configured for delivery to the heartthrough catheter 14 substantially along the catheter axis of catheter 14while the structure axis is substantially parallel to the catheter axis.One or more of anchors 32 (e.g., a plurality, as shown) are configuredfor delivery to a region of cardiac tissue from a proximal end ofcatheter 14 (e.g., through channel 18) toward a distal end of catheter14 and substantially along the structure axis of structure 222 and thecatheter axis of catheter 14 at the distal end of catheter 14 while atleast a portion of annuloplasty structure 222 is within the passage ofcatheter 14, as shown in FIGS. 20G-H.

Reference is now made to FIGS. 2-3, 6A-11, and 25. For someapplications, sheath 2104 functions as catheter 14. That is, anchors 32are delivered through a portion of a wall of sleeve 26 while at least aportion of annuloplasty ring 3022 is within a lumen of sheath 2104.

Reference-force tube 19 houses channel 18 (not shown), which comprisesan elongated and flexible anchor delivery channel sized and configuredto extend within the lumen of structure 222 while at least a portion ofstructure 222 is within the passage of catheter 14. For someapplications, the channel is steerable.

For some applications, channel 18 is configured to be advanced withstructure 222 during a period when catheter 14 is maintained in asubstantially constant position.

Kit 4000 comprises handle 24 which defines a first control mechanism,and handle 126 which defines a second control mechanism. The first andthe second control mechanisms are configured to enable independentmovement and steering of catheter 14 channel 18, respectively.Typically, the first control mechanism and the second control mechanismare configured to enable incremental release of the annuloplastystructure from a distal end of channel 18 as the plurality of anchorsare sequentially deployed from within channel 18. Typically, theplurality of anchors 32 are configured for location within channel 18(e.g., each anchor at different times), a distal end of channel 18 isconfigured for location within the lumen of structure 222, and structure222 is configured for location at least partially within the lumen ofcatheter 14.

As shown, kit 4000 comprises catheter 12 which defines an elongatedintroducer shaft sized for delivery through the vasculature, theintroducer shaft defining a lumen and having an elongated shaft axisextending therethrough, wherein the lumen is sized and configured tohold at least a portion of catheter 14 therein while the catheter axisis substantially parallel to the shaft axis (i.e., the axis of catheter12). Handle 22 defines a catheter control mechanism and a introducercontrol mechanism configured to enable independent movement of catheter12 and the introducer shaft. As described hereinabove with reference toFIGS. 13-15E and 22A-D, catheter 12 is shaped so as to define firstcoupling 152 is shaped so as to define slit 52 for receiving engager 54comprising a detent). Such first coupling 152 defines a first lockingmechanism located at a distal region of catheter 12. A second lockingmechanism is also provided for catheter 12, that is, protrusion-lockinglocation 1708 of housing 1702, described hereinabove with reference toFIGS. 22A-D. This second locking mechanism is located at a proximalregion of catheter 12. The first and the second locking mechanisms areconfigured to inhibit rotation of catheter 14 within the lumen ofcatheter 12.

For some applications, the first and the second locking mechanisms areconfigured to lock substantially simultaneously.

Although annuloplasty ring 3022 and ring structure 222 is describedhereinabove as being placed in an atrium, for some application the ringis instead placed in either the left or right ventricle.

Accordingly, it is noted that, annuloplasty ring 3022 and annuloplastyring structure 222 and other components of system 10 describedhereinabove and methods shown in the application can be used on anycardiac valve (e.g., the mitral, tricuspid, aortic, and/or pulmonary).

Although annuloplasty ring 3022 and structure 222 have been describedhereinabove as comprising a partial annuloplasty ring, in someapplications of the present invention, the ring instead comprises a fullannuloplasty ring.

Reference is now made to FIG. 26, which is a schematic illustration of astiffening element 1926, in accordance with some applications of thepresent invention. Stiffening element 1926 is threaded through sleeve26, so as to provide controllably-variable stiffness to sleeve 26. Forexample, one or more generally stiff stiffening elements 1926, e.g., awire or a suture, is woven one or more times (e.g., a plurality oftimes) through sleeve 26 to provide the stiffness, and subsequently beremoved at the conclusion of the implantation procedure when thestiffness is no longer useful.

Since channel 18 and components that are slidable therein aredeflectable and steerable, stiffening element 1926 helps maintain therelative positioning of channel 18 with respect to sleeve 26 in order toprevent channel 18 of the deployment manipulator from deploying ananchor through sleeve 26 in a vicinity of contracting member 226 (shownin FIG. 14). That is, stiffening element 1926 helps maintain the shapeand integrity of sleeve 26 (e.g., prevents flailing and/or kinking ofsleeve 26). Stiffening element 1926 helps ensure that the anchors aredeployed through sleeve 26 without interfering with contracting member226. For some applications, stiffening element 1926 additionally oralternatively facilitates positioning of portions of sleeve 26 and/oranchors 32, such as positioning of subsequent portions and/or anchorsfollowing positioning of previous portions and/or anchors.

For some applications, element 1926 is removed from sleeve 26 by beingpulled by an operating physician, e.g., using a tool. For otherapplications, element 1926 is coupled to another portion of system 10,such as a portion of channel 18, the deployment manipulator, or acomponent that is slidable within a lumen of the deployment manipulator,and is removed by being pulled either by the channel or the manipulatoror any component thereof. For some applications, stiffening element 1926(e.g., a proximal end thereof) is coupled to reference-force tube 19,and is pulled out of sleeve 26 (e.g., unthreaded from the sleeve)following release of the sleeve, as tube 19 is withdrawn proximally(e.g., as shown in blow-up B).

For some applications, stiffening element 1926 may comprise more thanone component, at least one of the components being removed from sleeve26, and at least one of the components remaining within the sleeve. Forsome applications, such stiffening elements may facilitate loading ofthe stiffening element into sleeve 26, removal of the stiffening element(or an element thereof) from the sleeve. For example, stiffening element1926 may comprise a relatively flexible tube, and a relatively stiff rodwithin the tube, the rod being pulled out of the tube in order to reducethe stiffness of the stiffening element and the sleeve. For someapplications, stiffening element 1926 may comprise a plurality ofrelatively stiff tubes, arranged in series, and a longitudinal member(e.g., a wire or a suture) disposed through the tubes, and fixedlycoupled to at least one of the tubes (e.g., a tube at the end of theseries). When the longitudinal member is under tension, the tubes areheld together (e.g., resembling one long tube), and the stiffeningelement is generally stiff along its overall length. When thelongitudinal member is released and/or removed, the tubes may separate,and although each tube remains relatively stiff, the stiffening elementbecomes less stiff along its overall length. For some applications, sucha stiffening element resembles a trick collapsing “magic wand.”

For some applications, the controllably-variable stiffness of sleeve 26is provided by stiffening element 1926 becoming less stiff (e.g.,without mechanically removing the stiffening element). For example, thestiffening element may be configured to become less stiff and/or todissolve at least in part over time and/or in response to being disposedwithin the body of the subject (e.g., due to temperature or bodyfluids). Alternatively or additionally, the stiffening element maycomprise a shape-memory or shape-change material having a transitiontemperature, the stiffening element being delivered in a configuration(e.g., a shape) that is relatively stiff, and transitioning (e.g., inresponse to provided electromagnetic, electrical, and/or heat energy) toa configuration (e.g., a shape) that is relative flexible.

Reference-force tube 19 is reversibly coupled and couplable to structure222, and the lumen of reference-force tube 19 is in fluid communicationwith the lumen of sleeve 26. Stiffening element 1926 is couplable tosleeve 26 and to reference-force tube 19 such that progressive proximalmovement of reference-force tube 19 away from sleeve 26 by unthreadingstiffening element 1926 from sleeve 26, which (1) decouples stiffeningelement 1926 from sleeve 26, (2) decouples stiffening element 1926 fromprogressively proximal portions of sleeve 26, and (3) reduces theinhibition of the flexibility of progressively proximal portions ofsleeve 26.

Reference is now made to FIGS. 27A-B, which are schematic illustrationsof a catheter 5340 having multiple steering segments (e.g., first andsecond steering segments 5348 and 5346, respectively), in accordancewith some applications of the present invention. First steering segment5348 comprises a first pull ring 5343 that is coupled to respectivedistal ends of first and second first-segment steering wires 5342 a and5342 b. Steering wires 5342 a and 5342 b extend from pull ring 5343toward a proximal portion of catheter 5340. Second steering segment 5346comprises a second pull ring 5345 that is coupled to respective distalends of first and second second-segment steering wires 5344 a and 5344b. Steering wires 5344 a and 5344 b extend from the distal end ofcatheter 5340 toward a proximal portion of catheter 5340.

Segment 5346 is configured to be coupled to only steering wires 5344 aand 5344 b. Steering wires 5344 a and 5344 b pass through respectivechannels provided by pull ring 5343.

In response to the pulling of wires 5342 a and 5342 b steering segment5348 is steered in a first plane, and in response to the pulling ofwires 5344 a and 5344 b steering segment 5346 is steered in a secondplane, which second plane is at a non-zero angle with respect to thefirst plane (e.g., generally perpendicular to the first plane). Forapplications in which catheter 5340 is used to deliver annuloplastystructures 222 and 3022 described herein and anchor driver 36 describedherein to a cardiac valve, segment 5348 is configured to be steered inthe plane that is parallel with respect to the valve, and segment 5346is configured to be steered toward the valve in a second plane that isperpendicular with respect to the plane of the valve.

For some applications catheter 5340 may be introduced withinmulti-component tubular system 10, described hereinabove with referenceto FIGS. 13 and 24, in place of catheters 12 and 14. That is referenceforce tube 19, structure 222, channel 18, and deployment manipulator 61may be advanced within a lumen of catheter 5340.

Reference is made to FIG. 28, which is a schematic illustration of astate of a distal portion of catheter 5340, in accordance with someapplications of the invention. The distal portion of catheter 5340 issteerable (i) in a first plane, and (2) in a second plane that istypically perpendicular to the first plane, and (iii) distal portions ofsleeve 26 are laid along the annulus 240 of the native valve whileproximal portions of the sleeve (and the distal end of manipulator 61,within the sleeve) are disposed at a nonzero angle with respect to theannulus. Thus, catheter 5340 is configured to assume multi-bendformation 2948 (e.g., a proximal extracorporeal handle portion isconfigured to configure catheter 5340 and structure 222 to assume themulti-bend formation) in which at least three domains 2950, and at leasttwo bends 2952 separating the domains, are defined.

The formation includes (i) a first bend 2952 a that separates a firstdomain 2950 a of the formation from a second domain 2950 b of theformation, and (ii) a second bend 2952 b that separates the seconddomain from a third domain 2950 c of the formation. Typically, theformation further includes a third bend 2952 c that separates firstdomain 2950 a from a fourth domain 2950 d of the formation. First domain2950 a comprises at least (1) a distal part of steering segment 5348,and (2) typically further comprises at least part of sleeve 26 (i.e., atleast part of sleeve 26 disposed within catheter 5340). Second domain2950 b comprises at least part of steering segment 5346 and at least amiddle part of sleeve 26 (e.g., the second domain comprises at leastpart of sleeve 26 disposed within a distal end portion of catheter 5340and that is exposed from catheter 5340) and none of steering segment5348. Third domain 2950 c comprises at least part of sleeve 26, and noneof catheter 5340 (i.e., the third domain comprises a distal part ofsleeve 26 that is disposed out of the distal end of catheter 5340). Inapplications in which formation 2948 includes third bend 2952 c andfourth domain 2950 d, the fourth domain comprises at least part ofcatheter 5340 at steering segment 5348 that is proximal to bend 2952 cand may further comprise at least part of sleeve 26 (i.e., at least aproximal part of sleeve 26 disposed within catheter 5340). Thus, domains2950 a and 2950 d are typically of similar composition, but separated bythird bend 2952 c.

As shown, during anchoring of sleeve 26 (e.g., typically duringanchoring of a second anchor 32 bb), a generally-triangular shape isformed between: (1) guide member 86, (2) a distal portion of sleeve 26,and (3) channel 18 surrounded partially by catheter 5340. It is to benoted that the illustrated triangle is shown in phantom to indicate therelative triangular orientation of the three components, and that theillustrated triangle is not a part of the apparatus shown. For example,a generally-triangular shape is formed in the apparatus between: (1) theguide member, (2) the distal portion of the implant structure at atleast a portion of the third domain, and (3) at least a portion of thesecond domain.

Reference is now made to FIGS. 6A-I, 20A-I, and 28. It is to be notedthat techniques for implantation of structure 222 for creating themulti-bend structure shown in FIG. 28 may be employed in techniquesdescribed for implantation of ring 3022 in FIGS. 6A-I and in techniquesdescribed for implantation of structure 222 in FIGS. 20A-I. For example,the multi-bend formation 2948 is shown in FIG. 6H.

Reference is now made to FIGS. 6H and 28. When catheter 5340 formsmulti-bend formation 2948, a first-deployed tissue anchor 32 aa anchorsa distal end portion of the longitudinal implant (i.e., ring 3022 inFIG. 6H and structure 222 in FIG. 24) to tissue of the subject. Tissueanchor 32 aa facilitates the formation of second bend 2952 b before andduring placement of a second-deployed anchor 32 bb by applying areference force to the implant at the distal end portion of the implant.Additionally, the tube that is disposed within the sleeve 26 (i.e.,manipulator 61 in FIG. 6H and channel 18 in FIG. 28) facilitates theformation of second bend 2952 b before and during placement of asecond-deployed anchor 32 bb by applying a reference force to theimplant along the second domain 2950 b.

Reference is made to FIGS. 6A-I and 28. It is to be noted thatannuloplasty ring 3022 of FIGS. 6A-I can be used in the procedure asdescribed in FIG. 28, and structure 222 of FIG. 28 can be used in theprocedure as described in FIGS. 6A-I. Additionally, manipulator 61 ofFIGS. 6A-I can be used in the procedure as described in FIG. 28, andchannel 18 of FIG. 28 can be used in the procedure as described in FIGS.6A-I.

In some applications of the present invention, system 10 is used totreat an atrioventricular valve other than the mitral valve, i.e., thetricuspid valve. In these embodiments, annuloplasty ring 3022, structure222, and other components of system 10 described hereinabove as beingplaced in the left atrium are instead placed in the right atrium.Although annuloplasty ring 3022 and structure 222 are describedhereinabove as being placed in an atrium, for some application the ringis instead placed in either the left or right ventricle.

Additionally, the scope of the present invention includes embodimentsdescribed in the following applications, which are incorporated hereinby reference. In an embodiment, techniques and apparatus described inone or more of the following applications are combined with techniquesand apparatus described herein:

-   -   U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,        “Adjustable partial annuloplasty ring and mechanism therefor,”        filed on December 3022, 2008, which published as US Patent        Application Publication 2010/0161047 and issued as U.S. Pat. No.        8,241,351;    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which published as US Patent        Application Publication 2010/0161041 and issued as U.S. Pat. No.        8,147,542;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which published as US Patent Application        Publication 2010/0286767, and which issued as U.S. Pat. No.        8,715,342;    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Aug. 27, 2009, which published as US Patent Application        Publication 2010/0161042, and which issued as U.S. Pat. No.        8,808,368;    -   PCT Patent Application PCT/IL2009/001209 to Cabiri et al.,        entitled, “Adjustable annuloplasty devices and mechanisms        therefor,” filed on December 3022, 2009, which published as PCT        Publication WO 10/073246;    -   PCT Patent Application PCT/IL2010/000357 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        May 4, 2010, which published as WO 10/128502;    -   PCT Patent Application PCT/IL2010/000358 to Zipory et al.,        entitled, “Deployment techniques for annuloplasty ring and        over-wire rotation tool,” filed on May 4, 2010, which published        as WO 10/128503; and/or    -   PCT Patent Application PCT/IL2012/050451 to Sheps et al.,        entitled, “Controlled steering functionality for        implant-delivery tool,” filed on Nov. 8, 2012, and which        published as WO 13/069019.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1. A system for repairing a cardiac valve, the system comprising: acatheter sized for delivery through vasculature of a subject, thecatheter defining a delivery passage and having a catheter axisextending therethrough; an elongated and flexible annuloplasty structuredefining an annuloplasty structure axis, and being sized and configuredfor delivery to a heart of the subject through the cathetersubstantially along the catheter axis while the annuloplasty structureaxis is substantially parallel to the catheter axis; and multipleanchors, each configured for delivery from a proximal end of thecatheter, toward the annuloplasty structure and the heart substantiallyalong the annuloplasty structure axis and the catheter axis while atleast a portion of the annuloplasty structure is within the deliverypassage of the catheter.
 2. The system according to claim 1, furthercomprising an elongated and flexible deployment manipulator thatcomprises an anchor driver sized and configured to, while at least theportion of the annuloplasty structure is within the delivery passage ofthe catheter, for each of the multiple anchors sequentially: deliver theanchor from the proximal end of the catheter, toward the annuloplastystructure and the heart substantially along the annuloplasty structureaxis and the catheter axis, advance the anchor along at least theportion of the annuloplasty structure by the anchor driver extendingalong the annuloplasty structure, and anchor the annuloplasty structureto tissue of the heart by driving the anchor into the tissue.
 3. Thesystem according to claim 2, wherein the deployment manipulator issteerable.
 4. The system according to claim 2, further comprising afirst control mechanism and a second control mechanism, wherein thefirst and the second control mechanisms are configured to enableindependent movement of the catheter and the deployment manipulator,respectively.
 5. The system according to claim 4, wherein the firstcontrol mechanism and the second control mechanism are configured toenable incremental release of the annuloplasty structure from thecatheter as the multiple anchors are sequentially driven into thetissue.
 6. The system according to claim 1, wherein the cardiac valve isa mitral valve of the heart, and the system is for repairing the mitralvalve.
 7. The system according to claim 1, wherein the cardiac valve isa tricuspid valve of the heart, and the system is for repairing thetricuspid valve.
 8. The system according to claim 1, wherein: thecatheter is an inner catheter, and the system further comprises an outercatheter sized for delivery through the vasculature, the outer catheterdefining an outer catheter lumen and having an outer catheter axisextending therethrough, wherein the outer catheter lumen is sized andconfigured to hold at least a portion of the inner catheter thereinwhile the inner catheter is substantially parallel to the outer catheteraxis.
 9. The system according to claim 8, wherein: the inner catheter issteerable in a plane, and the system is configured to assume amulti-bend formation in which: a first bend of the formation separates afirst domain of the formation from a second domain of the formation, asecond bend of the formation separates the second domain of theformation from a third domain of the formation, the first domaincomprises at least (i) part of the outer catheter and (ii) a first partof the inner catheter, the second domain (i) comprises a second part ofthe inner catheter, a first part of the annuloplasty structure, and noneof the outer catheter, and (ii) is disposed in the plane, and the thirddomain (i) comprises a second part of the annuloplasty structure, noneof the outer catheter, and none of the inner catheter, and (ii) extendsout of the plane.
 10. The system according to claim 8, furthercomprising an inner catheter control mechanism and an outer cathetercontrol mechanism configured to enable independent movement of the innercatheter and the outer catheter.
 11. The system according to claim 8,further comprising a first locking mechanism located at a distal regionof the inner catheter and a second locking mechanism located at aproximal region of the inner catheter, wherein the first and the secondlocking mechanisms are configured to inhibit rotation of the innercatheter with respect to the outer catheter.
 12. The system according toclaim 11, wherein the first locking mechanism comprises a detent. 13.The system according to claim 12, wherein the first and the secondlocking mechanisms are configured to lock substantially simultaneously.14. The system according to claim 1, wherein the annuloplasty structurehas an elongate lumen, and wherein each of the multiple anchors isdeliverable along the elongate lumen, and is configured to, from withinthe elongate lumen, penetrate and pass through material of theannuloplasty structure.
 15. A method for repairing a valve of a heart ofa subject, the valve being disposed between an atrium and a ventricle ofthe heart, and the method comprising: transluminally advancing acatheter to the atrium, the catheter defining a delivery passage andhaving a catheter axis extending therethrough; delivering an elongatedand flexible annuloplasty structure to the atrium through the cathetersubstantially along the catheter axis while the annuloplasty structureis substantially parallel to the catheter axis; and anchoring theannuloplasty structure to an annulus of the valve by sequentially, foreach of multiple anchors: delivering the anchor from a proximal end ofthe catheter toward the annuloplasty structure and the heart along theannuloplasty structure and the catheter axis while at least a portion ofthe annuloplasty structure is within the delivery passage of thecatheter, and from within the atrium, driving the anchor into theannulus.
 16. The method according to claim 15, further comprising, foreach of the multiple anchors sequentially, engaging the anchor with ananchor driver, wherein delivering the anchor comprises delivering theanchor by advancing the anchor driver, engaged with the anchor, throughthe catheter toward the annuloplasty structure and the heartsubstantially along the catheter axis while at least the portion of theannuloplasty structure is within the delivery passage of the catheter.17. The method according to claim 15, wherein the valve is a mitralvalve of the heart, and transluminally advancing the catheter to theatrium comprises transluminally advancing the catheter to a left atriumof the heart.
 18. The method according to claim 15, wherein the valve isa tricuspid valve of the heart, and transluminally advancing thecatheter to the atrium comprises transluminally advancing the catheterto a right atrium of the heart.
 19. The method according to claim 15,wherein the annuloplasty structure has an elongate lumen, and whereinanchoring the annuloplasty structure to the annulus comprises, fromwithin the elongate lumen, penetrating and passing each of the multipleanchors though material of the annuloplasty structure.
 20. The methodaccording to claim 15, wherein: the catheter is an inner catheter, andis steerable in a plane; delivering the annuloplasty structure to theatrium comprises delivering the annuloplasty structure to the atriumsubstantially along the catheter axis while (i) the annuloplastystructure is substantially parallel to the catheter axis, and (ii) theinner catheter extends distally through and out of an outer catheter;for at least one of the multiple anchors, driving the anchor into theannulus comprises driving the anchor into the annulus while the outercatheter, the inner catheter, and the annuloplasty structure arecollectively in a multi-bend formation in which: a first bend of theformation separates a first domain of the formation from a second domainof the formation, a second bend of the formation separates the seconddomain of the formation from a third domain of the formation, the firstdomain comprises at least (i) part of the outer catheter and (ii) afirst part of the inner catheter, the second domain (i) comprises asecond part of the inner catheter, a first part of the annuloplastystructure, and none of the outer catheter, and (ii) is disposed in theplane, and the third domain (i) comprises a second part of theannuloplasty structure, none of the outer catheter, and none of theinner catheter, and (ii) extends out of the plane.